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ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 14 USDMF, 12 CEP/COS, 4 JDMF, 3 EU WC, 4 KDMF, 16 NDC API, 17 Listed Suppliers, $ API Reference Price

32 API Suppliers
14 USDMF
12 CEP/COS
4 JDMF
3 EU WC
4 KDMF
16 NDC API
17 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

379 FDF Dossiers, 77 FDA Orange Book, 159 Europe, 25 Canada, 75 Australia, 17 South Africa, 26 Listed Dossiers

379 FDF Dossiers
77 FDA Orange Book
159 Europe
25 Canada
75 Australia
17 South Africa
26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE, TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE
TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE
TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE
TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE
TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE
TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE
TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 17 SPI Pharma, 4 Faran Shimi Pharmaceutical, 2 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Finar, 5 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 17 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 8 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

59 Fillers, Diluents & Binders, 42 Coating Systems & Additives, 34 Direct Compression, 28 Disintegrants & Superdisintegrants, 23 Controlled & Modified Release, 18 Thickeners and Stabilizers, 17 Taste Masking, 16 Granulation, 15 Chewable & Orodispersible Aids, 15 Co-Processed Excipients, 11 Lubricants & Glidants, 11 Film Formers & Plasticizers, 9 Parenteral, 5 Empty Capsules, 5 API Stability Enhancers, 5 Solubilizers, 4 Vegetarian Capsules, 3 Emulsifying Agents, 3 Topical, 3 Rheology Modifiers, 2 Coloring Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 35 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
35 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 103 Finished Drug Prices

globalSalesInformation
2 US Medicaid Prescriptions
103 Finished Drug Prices

MARKET PLACE

11 APIs, 5 FDF Dossiers

marketPlace
11 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

36 US Patents, 17 Health Canada Patents

patents
36 US Patents
17 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 1 USP , 3 Others

otherSolutions
2 EDQM
1 USP
3 Others

Aspen Fentanyl Citrate

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 64,860

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

379

FDF Dossiers

FDA Orange Book

159

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

4,912,369

Annual Reports (USD Million)

Finished Drug Prices

190 RELATED EXCIPIENT COMPANIES

328EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 990-73-8, Leptanal, Phentanyl citrate, Actiq, Fentanyl dihydrogen citrate, Abstral

Molecular Formula

C₂₈H₃₆N₂O₈

Molecular Weight

528.6 g/mol

InChI Key

IVLVTNPOHDFFCJ-UHFFFAOYSA-N

FDA UNII

MUN5LYG46H

A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078)

1 2D Structure

Fentanyl Citrate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-hydroxypropane-1,2,3-tricarboxylic acid;N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]propanamide

2.1.2 InChI

InChI=1S/C22H28N2O.C6H8O7/c1-2-22(25)24(20-11-7-4-8-12-20)21-14-17-23(18-15-21)16-13-19-9-5-3-6-10-19;7-3(8)1-6(13,5(11)12)2-4(9)10/h3-12,21H,2,13-18H2,1H3;13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)

2.1.3 InChI Key

IVLVTNPOHDFFCJ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CCC(=O)N(C1CCN(CC1)CCC2=CC=CC=C2)C3=CC=CC=C3.C(C(=O)O)C(CC(=O)O)(C(=O)O)O

2.2 Other Identifiers

2.2.1 UNII

MUN5LYG46H

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Duragesic

2. Durogesic

3. Fentanest

4. Fentanyl

5. Fentora

6. Phentanyl

7. R 4263

8. R-4263

9. R4263

10. Sublimaze

11. Transmucosal Oral Fentanyl Citrate

2.3.2 Depositor-Supplied Synonyms

1. 990-73-8

2. Leptanal

3. Phentanyl Citrate

4. Actiq

5. Fentanyl Dihydrogen Citrate

6. Abstral

7. Fentanyl Citrate Salt

8. Lazanda

9. Onsolis

10. Mcn-jr-4263-49

11. Instanyl

12. Fentanyl Buccal

13. Fentanyl Citrate Cii

14. Mun5lyg46h

15. Oralet

16. N-(1-phenethyl-4-piperidyl)propionanilide Citrate

17. N-(1-phenethyl-4-piperidyl)propionanilide Citrate (1:1)

18. N-(1-phenethyl-4-piperidyl)propionanilide Dihydrogen Citrate

19. Chebi:31602

20. Fentaz

21. N-(1-phenethyl-4-piperidinyl)propionanilide Dihydrogen Citrate

22. R-4263

23. Kw-2246

24. Propanamide, N-phenyl-n-(1-(2-phenylethyl)-4-piperidinyl)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

25. N-(1-phenethylpiperidin-4-yl)-n-phenylpropionamide Citrate

26. Rapinyl

27. 2-hydroxypropane-1,2,3-tricarboxylic Acid;n-phenyl-n-[1-(2-phenylethyl)piperidin-4-yl]propanamide

28. Mcn-jr 4263

29. Sublimaze Preservative Free

30. Einecs 213-588-0

31. Unii-mun5lyg46h

32. Fentanyl Citrate Preservative Free

33. R 5240

34. Fentanyl Monocitrate

35. Abstral (tn)

36. Fentora (tn)

37. Lazanda (tn)

38. Oralet (tn)

39. Fentanyl Citrate [usan:usp:ban:jan]

40. Propionanilide, N-(1-phenethyl-4-piperidyl)-, Citrate (1:1)

41. Chembl688

42. Schembl40733

43. Fentanyl Citrate [mi]

44. Fentanyl Citrate [jan]

45. Fentanyl Citrate (jp17/usp)

46. Fentanyl Citrate [usan]

47. Fentanyl Citrate [vandf]

48. Dtxsid80243933

49. Fentanyl Citrate [mart.]

50. Fentanyl Citrate [who-dd]

51. Fentanyl Citrate [ema Epar]

52. Fentanyl Citrate [green Book]

53. Akos024457504

54. Fentanyl Citrate [orange Book]

55. Fentanyl Citrate Cii [usp-rs]

56. Fentanyl Citrate [ep Monograph]

57. Fentanyl Citrate [usp Monograph]

58. Innovar Component Fentanyl Citrate

59. B5403

60. Fentanyl Citrate Component Of Innovar

61. D01399

62. 990f738

63. Q27104201

64. N-phenyl-n-[1-(2-phenylethyl)-4-piperidyl]propanamide Citrate

65. Fentanyl Citrate, European Pharmacopoeia (ep) Reference Standard

66. N-phenyl-n-[1-(2-phenylethyl)-4-piperidinyl]propanamide Citrate

67. Fentanyl Citrate, United States Pharmacopeia (usp) Reference Standard

68. Fentanyl Citrate Salt Solution, Drug Standard, 100 Mug/ml In Methanol: Tert-butanol (3:2)

69. N-(1-phenethylpiperidin-4-yl)-n-phenylpropionamide 2-hydroxypropane-1,2,3-tricarboxylate

70. N-phenyl-n-[1-(2-phenylethyl)piperidin-4-yl]propanamide 2-hydroxypropane-1,2,3-tricarboxylate

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₈H₃₆N₂O₈
Molecular Weight	528.6 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	9
Rotatable Bond Count	11
Exact Mass	528.24716611 g/mol
Monoisotopic Mass	528.24716611 g/mol
Topological Polar Surface Area	156 Å²
Heavy Atom Count	38
Formal Charge	0
Complexity	618
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
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	Abstral
PubMed Health	Fentanyl
Drug Classes	Analgesic, Anesthetic Adjunct
Drug Label	ABSTRAL (fentanyl) sublingual tablet is a solid formulation of fentanyl citrate, a potent opioid analgesic intended for oral sublingual administration. ABSTRAL is formulated as a white tablet available in six strengths, distinguishable by the shape o...
Active Ingredient	Fentanyl citrate
Dosage Form	Tablet
Route	Sublingual
Strength	eq 0.1mg base; eq 0.8mg base; eq 0.3mg base; eq 0.6mg base; eq 0.4mg base; eq 0.2mg base
Market Status	Prescription
Company	Galena Biopharma

2 of 8
Drug Name	Fentanyl citrate
Drug Label	Oral transmucosal fentanyl citrate is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. Oral transmucosal fentanyl citrate is formulated as a white to off-white solid drug matrix on a h...
Active Ingredient	Fentanyl citrate
Dosage Form	Injectable; Troche/lozenge
Route	Transmucosal; Injection
Strength	eq 0.05mg base/ml; eq 0.8mg base; eq 1.6mg base; eq 0.6mg base; eq 1.2mg base; eq 0.4mg base; eq 0.2mg base
Market Status	Prescription
Company	Hospira; Mallinckrodt; Par Pharm

3 of 8
Drug Name	Fentanyl citrate preservative free
Active Ingredient	Fentanyl citrate
Dosage Form	Injectable
Route	Injection
Strength	eq 0.05mg base/ml
Market Status	Prescription
Company	Hospira; Hikma Maple

4 of 8
Drug Name	Sublimaze preservative free
Active Ingredient	Fentanyl citrate
Dosage Form	Injectable
Route	Injection
Strength	eq 0.05mg base/ml
Market Status	Prescription
Company	Akorn

5 of 8
Drug Name	Abstral
PubMed Health	Fentanyl
Drug Classes	Analgesic, Anesthetic Adjunct
Drug Label	ABSTRAL (fentanyl) sublingual tablet is a solid formulation of fentanyl citrate, a potent opioid analgesic intended for oral sublingual administration. ABSTRAL is formulated as a white tablet available in six strengths, distinguishable by the shape o...
Active Ingredient	Fentanyl citrate
Dosage Form	Tablet
Route	Sublingual
Strength	eq 0.1mg base; eq 0.8mg base; eq 0.3mg base; eq 0.6mg base; eq 0.4mg base; eq 0.2mg base
Market Status	Prescription
Company	Galena Biopharma

6 of 8
Drug Name	Fentanyl citrate
Drug Label	Oral transmucosal fentanyl citrate is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. Oral transmucosal fentanyl citrate is formulated as a white to off-white solid drug matrix on a h...
Active Ingredient	Fentanyl citrate
Dosage Form	Injectable; Troche/lozenge
Route	Transmucosal; Injection
Strength	eq 0.05mg base/ml; eq 0.8mg base; eq 1.6mg base; eq 0.6mg base; eq 1.2mg base; eq 0.4mg base; eq 0.2mg base
Market Status	Prescription
Company	Hospira; Mallinckrodt; Par Pharm

7 of 8
Drug Name	Fentanyl citrate preservative free
Active Ingredient	Fentanyl citrate
Dosage Form	Injectable
Route	Injection
Strength	eq 0.05mg base/ml
Market Status	Prescription
Company	Hospira; Hikma Maple

8 of 8
Drug Name	Sublimaze preservative free
Active Ingredient	Fentanyl citrate
Dosage Form	Injectable
Route	Injection
Strength	eq 0.05mg base/ml
Market Status	Prescription
Company	Akorn

4.2 Drug Indication

Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.

Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Treatment of acute pain, Prevention of acute pain

Acute pain

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Analgesics, Opioid

Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)

Anesthetics, Intravenous

Ultrashort-acting anesthetics that are used for induction. Loss of consciousness is rapid and induction is pleasant, but there is no muscle relaxation and reflexes frequently are not reduced adequately. Repeated administration results in accumulation and prolongs the recovery time. Since these agents have little if any analgesic activity, they are seldom used alone except in brief minor procedures. (From AMA Drug Evaluations Annual, 1994, p174) (See all compounds classified as Anesthetics, Intravenous.)

Narcotics

Agents that induce NARCOSIS. Narcotics include agents that cause somnolence or induced sleep (STUPOR); natural or synthetic derivatives of OPIUM or MORPHINE or any substance that has such effects. They are potent inducers of ANALGESIA and OPIOID-RELATED DISORDERS. (See all compounds classified as Narcotics.)

Adjuvants, Anesthesia

Agents that are administered in association with anesthetics to increase effectiveness, improve delivery, or decrease required dosage. (See all compounds classified as Adjuvants, Anesthesia.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Opioid Agonist [EPC]; Full Opioid Agonists [MoA]

5.3 ATC Code

N02AB03

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API Reference Price

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INDL.ESTATE,","city":"MUMBAI ,MAHARASHTRA","supplier":"RUSAN PHARMA","supplierCountry":"INDIA","foreign_port":"ALGIERS","customer":"SPA LES LABORATOIRES ","customerCountry":"ALGERIA","quantity":"0.30","actualQuantity":"300","unit":"GMS","unitRateFc":"40","totalValueFC":"11864.7","currency":"USD","unitRateINR":3302.6233333333334,"date":"16-Apr-2024","totalValueINR":"990787","totalValueInUsd":"11864.7","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"9165988","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT NO.58-D,GOVT. INDL.ESTATE,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733682600,"product":"PHARMACEUTICAL RAW MATERIAL ACTIVEPHARMACEUTICAL INGREDIENT FENTANYL CITRATE USP","address":"206, ERIC HOUSE, 16TH ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"PIONEER AGRO INDUSTRIES SANVIN LABORATORIES PRIVAT","supplierCountry":"INDIA","foreign_port":"N\/A","customer":"G. 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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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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE

USFDA APPLICATION NUMBER - 20747

DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE

USFDA APPLICATION NUMBER - 20747

DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE

USFDA APPLICATION NUMBER - 20747

DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE

USFDA APPLICATION NUMBER - 20747

DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE

USFDA APPLICATION NUMBER - 20747

DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE

USFDA APPLICATION NUMBER - 20747

DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG...DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE