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24 API Suppliers, 13 USDMF, 10 CEP/COS, 3 JDMF, 2 EU WC, 1 KDMF, 11 NDC API, 10 Listed Suppliers, $ API Reference Price

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10 CEP/COS
3 JDMF
2 EU WC
1 KDMF
11 NDC API
10 Listed Suppliers
$ API Reference Price

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61 FDA Orange Book
12 Europe
10 Canada
5 South Africa
6 Listed Dossiers

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TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TRANSDERMAL - 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL;TRANSDERMAL - 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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2 Rochem International Inc
19 SPI Pharma
2 Seqens
5 DKSH
2 Jai Radhe Sales
7 Faran Shimi Pharmaceutical
1 Boai NKY Pharmaceuticals Ltd
14 Gangwal Healthcare
7 Nanjing Well Pharmaceutical
2 Pfanstiehl
1 ACG Worldwide
12 Actylis
1 Aeon Procare
2 Alcedo Pharmachem
9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
30 BASF
1 Clariant
14 Corel Pharma Chem
7 DFE Pharma
3 Doshion Polyscience
2 Finar
12 Gangwal Chemicals
9 Ideal Cures Pvt Ltd
5 Ingredion Pharma Solutions
37 Kerry
3 Kima Chemical
6 Lonza Capsugel
16 Microlex e.U
1 Nanjing Bold Chemical
2 Nomisma Healthcare
2 Novo Excipients
3 Pharmatrans-Sanaq
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4 Prachin Chemical
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1 Qualicaps
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2 Shijiazhuang Huaxu Pharmaceutical
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2 Valens Pharmachem
5 Vasa Pharmachem
1 Vertellus
1 Zhejiang Huakang Pharmaceutical

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Synopsis

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API REF. PRICE (USD/KG)

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330 RELATED EXCIPIENT COMPANIES

552EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Oxybutynin hydrochloride, 1508-65-2, Oxybutynin hcl, Tropax, Oxybutynin (chloride), Ditropan xl

Molecular Formula

C₂₂H₃₂ClNO₃

Molecular Weight

393.9 g/mol

InChI Key

SWIJYDAEGSIQPZ-UHFFFAOYSA-N

FDA UNII

L9F3D9RENQ

Oxybutynin Chloride is the chloride salt form of oxybutynin, a tertiary amine and anticholinergic agent with antispasmodic activity. Oxybutynin chloride exerts its antimuscarinic effect on bladder smooth muscle by blocking muscarinic receptors in smooth muscle, thereby inhibiting acetylcholine binding. This results in a relaxation of bladder smooth muscle, a reduction of involuntary muscle contractions and delays the initial desire to void.

1 2D Structure

Oxybutynin Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate;hydrochloride

2.1.2 InChI

InChI=1S/C22H31NO3.ClH/c1-3-23(4-2)17-11-12-18-26-21(24)22(25,19-13-7-5-8-14-19)20-15-9-6-10-16-20;/h5,7-8,13-14,20,25H,3-4,6,9-10,15-18H2,1-2H3;1H

2.1.3 InChI Key

SWIJYDAEGSIQPZ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CCN(CC)CC#CCOC(=O)C(C1CCCCC1)(C2=CC=CC=C2)O.Cl

2.2 Other Identifiers

2.2.1 UNII

L9F3D9RENQ

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 4-(diethylamino)-2-butynyl-alpha-cyclohexyl-alpha-hydroxybenzeneacetate

2. 4-(diethylamino)-2-butynyl-alpha-phenylcyclohexaneglycolate

3. Apo-oxybutynin

4. Contimin

5. Cystonorm

6. Cystrin

7. Ditropan

8. Dresplan

9. Dridase

10. Driptane

11. Gelnique

12. Gen-oxybutynin

13. Novo-oxybutynin

14. Nu-oxybutyn

15. Oxyb Abz

16. Oxybugamma

17. Oxybutin Holsten

18. Oxybuton

19. Oxybutynin

20. Oxybutynin Al

21. Oxybutynin Azu

22. Oxybutynin Heumann

23. Oxybutynin Hexal

24. Oxybutynin Hydrochloride

25. Oxybutynin Stada

26. Oxybutynin Von Ct

27. Oxybutynin-puren

28. Oxybutynin-ratiopharm

29. Oxymedin

30. Oxytrol

31. Pms-oxybutynin

32. Pollakisu

33. Renamel

34. Ryol

35. Spasmex Oxybutynin

36. Spasyt

37. Tavor

38. Zatur

2.3.2 Depositor-Supplied Synonyms

1. Oxybutynin Hydrochloride

2. 1508-65-2

3. Oxybutynin Hcl

4. Tropax

5. Oxybutynin (chloride)

6. Ditropan Xl

7. Pollakisu

8. Mj 4309-1

9. L9f3d9renq

10. Nsc-759108

11. Alpha-phenylcyclohexaneglycolic Acid 4-(diethylamino)-2-butynyl Ester Hydrochloride

12. Mls000069688

13. 4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate Hydrochloride

14. Dridase

15. Smr000058490

16. Mj-4309-1

17. 4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate;hydrochloride

18. Oxybutynin Hydrochloride (jan)

19. 4-diethylamino-2-butynyl Phenyl(cyclohexyl)glycolate Hydrochloride

20. 4-(diethylamino)-2-butynyl Alpha-phenylcyclohexaneglycolate Hydrochloride

21. Gelnique

22. Oxibutinina Hydrochloride

23. Oxybutynin Hydrochloride [jan]

24. Chebi:7857

25. 4-diethylaminobut-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylethanoate Hydrochloride

26. Oxybutynin Chloride [usan]

27. Oxybutyninhydrochloride

28. Sr-01000000184

29. Einecs 216-139-7

30. Unii-l9f3d9renq

31. 4-(diethylamino)but-2-ynyl Cyclohexylphenylglycolate Hydrochloride

32. Oxybutynin Chloride [usan:usp]

33. Ditropan (tn)

34. Gelnique (tn)

35. Prestwick_621

36. Mfcd00072150

37. Oxybutynin-d11 Hcl

38. 4-(diethylamino)but-2-yn-1-yl Cyclohexyl(hydroxy)phenylacetate Hydrochloride

39. Opera_id_1330

40. Ncgc00016583-01

41. Oxybutynin (hydrochloride)

42. Oxybutynin Chloride (usp)

43. Cas-1508-65-2

44. Chembl1133

45. Dsstox_cid_25356

46. Dsstox_rid_80822

47. Dsstox_gsid_45356

48. Schembl25751

49. Mls001148211

50. Mls002222232

51. Regid_for_cid_91505

52. Dtxsid3045356

53. Hy-b0267a

54. (s)-4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate Hydrochloride

55. Hms1568j16

56. Pharmakon1600-01505399

57. (r,s) - Oxybutynin Hydrochloride

58. Oxybutynin Chloride [vandf]

59. Bcp12138

60. Oxybutynin Chloride-(phenyl-[d5])

61. Tox21_110507

62. Tox21_500923

63. Nsc759108

64. Oxybutynin Chloride [usp-rs]

65. Oxybutynin Hydrochloride [mi]

66. S3117

67. 4-(diethylamino)-2-butynyl (+-)-alpha-phenylcyclohexaneglycolate Hydrochloride

68. Akos015895349

69. Ccg-213420

70. H33o205

71. Ks-1377

72. Lp00923

73. Nc00580

74. Nsc 759108

75. Cyclohexaneglycolic Acid, Alpha-phenyl-, 4-(diethylamino)-2-butynyl Ester, Hydrochloride

76. Oxybutynin Hydrochloride [mart.]

77. Ncgc00094234-01

78. Ncgc00094234-02

79. Ncgc00261608-01

80. Oxybutynin Chloride [orange Book]

81. Oxybutynin Hydrochloride [who-dd]

82. Benzeneacetic Acid, Alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl Ester Hydrochloride

83. Benzeneacetic Acid, Alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl Ester Hydrochloride, (+-)-

84. Bo166187

85. Oxybutynin Chloride [usp Impurity]

86. Oxybutynin Chloride [usp Monograph]

87. Eu-0100923

88. Ft-0603563

89. Ft-0673411

90. Ft-0673412

91. O0451

92. Oxybutynin Chloride, >=98% (tlc), Powder

93. Sw196787-4

94. A51042

95. D00722

96. O 2881

97. Oxybutynin Hydrochloride [ep Monograph]

98. Oxybutynin Hydrochloride [usp Impurity]

99. A809082

100. J-008750

101. Sr-01000000184-2

102. Sr-01000000184-7

103. Q27107600

104. Oxybutynin Chloride, Meets Ep, Usp Testing Specifications

105. Oxybutynin Chloride, United States Pharmacopeia (usp) Reference Standard

106. Oxybutynin Hydrochloride, British Pharmacopoeia (bp) Reference Standard

107. Oxybutynin Hydrochloride, European Pharmacopoeia (ep) Reference Standard

108. 2-cyclohexyl-2-hydroxy-2-phenylacetic Acid 4-(diethylamino)but-2-ynyl Ester Hcl

109. 4-(diethylamino)-2-butynyl (+/-)-,alpha.-phenylcyclohexaneglycolate Hydrochloride

110. 4-(diethylamino)but-2-yn-1-yl 2-cyclohexyl-2-hydroxy-2-phenylacetate Hydrochloride

111. 4-diethylamino-2-butynylphenyl(cyclohexyl)glycolatehydrochloride;oxybutynin Hcl

112. Alpha-phenylcyclohexaneglycolic Acid 4-(diethylamino)-2-butynyl Ester, Hydrochloride

113. Benezeneactetic Acid, .alpha.-cyclohexyl-.alpha.-hydroxy-,4-(diethylamino-2-butunyl Ester Hydrochloride,(+/-)-

114. Benzeneacetic Acid, .alpha.-cyclohexyl-.alpha.-hydroxy-, 4-(diethylamino)-2-butynyl Ester Hydrochloride, (+/-)-

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₂H₃₂ClNO₃
Molecular Weight	393.9 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	8
Exact Mass	393.2070716 g/mol
Monoisotopic Mass	393.2070716 g/mol
Topological Polar Surface Area	49.8 Å²
Heavy Atom Count	27
Formal Charge	0
Complexity	490
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 8
Drug Name	Ditropan xl
Drug Label	DITROPAN XL (oxybutynin chloride) is an antispasmodic, anticholinergic agent. Each DITROPAN XL Extended Release Tablet contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral admini...
Active Ingredient	Oxybutynin chloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	5mg; 10mg; 15mg
Market Status	Prescription
Company	Janssen Pharms

2 of 8
Drug Name	Gelnique
PubMed Health	Oxybutynin (By mouth)
Drug Classes	Urinary Antispasmodic
Drug Label	Oxybutynin is an antispasmodic, antimuscarinic agent. GELNIQUE (oxybutynin chloride) is a clear and colorless hydroalcoholic gel containing 100 mg oxybutynin chloride per gram of gel. GELNIQUE is available in a 1 gram (1.14 mL) unit dose that contain...
Active Ingredient	Oxybutynin chloride
Dosage Form	Gel
Route	Transdermal
Strength	10%(100mg/packet)
Market Status	Prescription
Company	Watson Labs

3 of 8
Drug Name	Oxybutynin chloride
Drug Label	Oxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor...
Active Ingredient	Oxybutynin chloride
Dosage Form	Tablet, extended release; Tablet; Syrup
Route	Oral
Strength	15mg; 5mg; 10mg; 5mg/5ml
Market Status	Prescription
Company	Vintage Pharms; Impax Pharms; Mylan Pharms; Wockhardt; Silarx; Pharm Assoc; Teva Pharms Usa; Osmotica Pharm; Usl Pharma; Mylan

4 of 8
Drug Name	Oxybutynin chloride
PubMed Health	Oxybutynin
Drug Classes	Urinary Antispasmodic
Drug Label	Oxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor...
Active Ingredient	Oxybutynin chloride
Dosage Form	Tablet, extended release
Route	oral
Strength	15 mg.
Market Status	Prescription
Company	Mylan Pharms

5 of 8
Drug Name	Ditropan xl
Drug Label	DITROPAN XL (oxybutynin chloride) is an antispasmodic, anticholinergic agent. Each DITROPAN XL Extended Release Tablet contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral admini...
Active Ingredient	Oxybutynin chloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	5mg; 10mg; 15mg
Market Status	Prescription
Company	Janssen Pharms

6 of 8
Drug Name	Gelnique
PubMed Health	Oxybutynin (By mouth)
Drug Classes	Urinary Antispasmodic
Drug Label	Oxybutynin is an antispasmodic, antimuscarinic agent. GELNIQUE (oxybutynin chloride) is a clear and colorless hydroalcoholic gel containing 100 mg oxybutynin chloride per gram of gel. GELNIQUE is available in a 1 gram (1.14 mL) unit dose that contain...
Active Ingredient	Oxybutynin chloride
Dosage Form	Gel
Route	Transdermal
Strength	10%(100mg/packet)
Market Status	Prescription
Company	Watson Labs

7 of 8
Drug Name	Oxybutynin chloride
Drug Label	Oxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor...
Active Ingredient	Oxybutynin chloride
Dosage Form	Tablet, extended release; Tablet; Syrup
Route	Oral
Strength	15mg; 5mg; 10mg; 5mg/5ml
Market Status	Prescription
Company	Vintage Pharms; Impax Pharms; Mylan Pharms; Wockhardt; Silarx; Pharm Assoc; Teva Pharms Usa; Osmotica Pharm; Usl Pharma; Mylan

8 of 8
Drug Name	Oxybutynin chloride
PubMed Health	Oxybutynin
Drug Classes	Urinary Antispasmodic
Drug Label	Oxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor...
Active Ingredient	Oxybutynin chloride
Dosage Form	Tablet, extended release
Route	oral
Strength	15 mg.
Market Status	Prescription
Company	Mylan Pharms

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Muscarinic Antagonists

Drugs that bind to but do not activate MUSCARINIC RECEPTORS, thereby blocking the actions of endogenous ACETYLCHOLINE or exogenous agonists. Muscarinic antagonists have widespread effects including actions on the iris and ciliary muscle of the eye, the heart and blood vessels, secretions of the respiratory tract, GI system, and salivary glands, GI motility, urinary bladder tone, and the central nervous system. (See all compounds classified as Muscarinic Antagonists.)

Parasympatholytics

Agents that inhibit the actions of the parasympathetic nervous system. The major group of drugs used therapeutically for this purpose is the MUSCARINIC ANTAGONISTS. (See all compounds classified as Parasympatholytics.)

Urological Agents

Drugs used in the treatment of urological conditions and diseases such as URINARY INCONTINENCE and URINARY TRACT INFECTIONS. (See all compounds classified as Urological Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Cholinergic Muscarinic Antagonists [MoA]; Cholinergic Muscarinic Antagonist [EPC]

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API Reference Price

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PHARMACEUTICALS","customerCountry":"INDIA","quantity":"14.00","actualQuantity":"14","unit":"KGS","unitRateFc":"600","totalValueFC":"8500.4","currency":"USD","unitRateINR":"50610","date":"11-May-2024","totalValueINR":"708540","totalValueInUsd":"8500.4","indian_port":"Bombay Air","hs_no":"29221990","bill_no":"3433144","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"SITE DE SELOC FRANCE-19, ROUTE DEMEULAN 78520, LIMAYSDNF France","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722450600,"product":"1032182: OXYBUTYNIN CHLORIDE","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"SEQENS","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"110.00","actualQuantity":"110","unit":"KGS","unitRateFc":"600","totalValueFC":"66528.3","currency":"USD","unitRateINR":"50730","date":"01-Aug-2024","totalValueINR":"5580300","totalValueInUsd":"66528.3","indian_port":"Bombay Air","hs_no":"29221990","bill_no":"4813670","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"19 ROUTE DE MEULAN 78520 LIMAY FRANCESDNF France","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727893800,"product":"OXYBUTYNIN HYDROCHLORIDE-OXYBUTYNIN CHLORIDE","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"SEQENS","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"VIATRIS","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"1395","totalValueFC":"78610","currency":"EUR","unitRateINR":"132106.5","date":"03-Oct-2024","totalValueINR":"6605325","totalValueInUsd":"78610","indian_port":"Bombay Air","hs_no":"29221990","bill_no":"5922809","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"Centre administratif Campus Eiffel - Batiment Lavoisier - 11, Rue Ella Maillart 91300 Massy France","customerAddress":"564\/A\/22, ROAD NO.92"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20897

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20897

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG ...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20897

DOSAGE - GEL;TRANSDERMAL - 10% (100MG/PACKET)...DOSAGE - GEL;TRANSDERMAL - 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22204

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Oxybutynin Chloride

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ACTIVE PHARMA INGREDIENTS

24 API Suppliers

13 USDMF

10 CEP/COS

3 JDMF

2 EU WC

1 KDMF

11 NDC API

10 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

94 FDF Dossiers

61 FDA Orange Book

12 Europe

10 Canada

5 South Africa

6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;TRANSDERMAL - 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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TABLET, EXTENDED RELEASE;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL;TRANSDERMAL - 10% (100MG/PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons