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American Regent
FDA Orange Book

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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American Regent

VISIT THE VIRTUAL BOOTH, Contact Details

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EVENTS

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DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 13 NEWS #PharmaBuzz

INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
13 NEWS #PharmaBuzz

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

FINISHED DOSAGE FORMULATIONS

113 FDF Dossiers, 113 FDA Orange Book

113 FDF Dossiers
113 FDA Orange Book

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filter Active Ingredients Reset all filters

113 All

01 2ACETYLCYSTEINE

02 1ADENOSINE

03 1AMINOPHYLLINE

04 2ATROPINE SULFATE

05 1BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

06 1BUPRENORPHINE HYDROCHLORIDE

07 1BUSULFAN

08 2CAFFEINE CITRATE

09 2CALCITRIOL

10 1CALCIUM CHLORIDE

11 1CHLOROTHIAZIDE SODIUM

12 2CLONIDINE HYDROCHLORIDE

13 1CUPRIC SULFATE

14 3CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE

15 1CYANOCOBALAMIN

16 1DACTINOMYCIN

17 1DESMOPRESSIN ACETATE

18 1DEXMEDETOMIDINE HYDROCHLORIDE

19 1DEXTROSE

20 1DICYCLOMINE HYDROCHLORIDE

21 3DOPAMINE HYDROCHLORIDE

22 1DORZOLAMIDE HYDROCHLORIDE

23 1DROPERIDOL

24 2EPINEPHRINE

25 1ESMOLOL HYDROCHLORIDE

26 2ESTRADIOL VALERATE

27 4FERRIC CARBOXYMALTOSE

28 6FERRIC OXYHYDROXIDE

29 1FLOXURIDINE

30 1FOMEPIZOLE

31 2FOSPHENYTOIN SODIUM

32 1FUROSEMIDE

33 1GANCICLOVIR SODIUM

34 2GEMCITABINE HYDROCHLORIDE

35 1GLYCOPYRROLATE

36 1GRANISETRON HYDROCHLORIDE

37 1HYDRALAZINE HYDROCHLORIDE

38 2HYDROXYZINE HYDROCHLORIDE

39 1ISOPROTERENOL HYDROCHLORIDE

40 1ISOSULFAN BLUE

41 1LEUCOVORIN CALCIUM

42 1LEVETIRACETAM

43 1LEVOCARNITINE

44 2LIDOCAINE HYDROCHLORIDE

45 1METHOCARBAMOL

46 1METHYLDOPATE HYDROCHLORIDE

47 1METHYLERGONOVINE MALEATE

48 1METOPROLOL TARTRATE

49 1NANDROLONE DECANOATE

50 2NEOSTIGMINE METHYLSULFATE

51 1NICARDIPINE HYDROCHLORIDE

52 1NITROGLYCERIN

53 1OLANZAPINE

54 1ONDANSETRON

55 3ONDANSETRON HYDROCHLORIDE

56 2OXALIPLATIN

57 1PACLITAXEL

58 2PAMIDRONATE DISODIUM

59 1PHENYTOIN SODIUM

60 3POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

61 1PROGESTERONE

62 1PROMETHAZINE HYDROCHLORIDE

63 3SELENIOUS ACID

64 3SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

65 3STERILE WATER FOR INJECTION

66 1TESTOSTERONE CYPIONATE

67 2TORSEMIDE

68 1TRANEXAMIC ACID

69 2TRIMETHOBENZAMIDE HYDROCHLORIDE

70 2VASOPRESSIN

71 1ZIDOVUDINE

72 3ZINC SULFATE

filter Dosage Reset all filters

113 All

01 1INJECTABLE; INJECTION

02 63INJECTABLE;INJECTION

03 1INJECTABLE;INTRAMUSCULAR

04 8INJECTABLE;INTRAVENOUS

05 3LIQUID;N/A

06 1POWDER;INTRAVENOUS

07 1SOLUTION/DROPS;OPHTHALMIC

08 1SOLUTION;IM-IV

09 2SOLUTION;INHALATION, ORAL

10 2SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

11 28SOLUTION;INTRAVENOUS

12 1SOLUTION;ORAL

13 1SOLUTION;SUBCUTANEOUS

filter Dosage Strength Reset all filters

113 All

01 10.001MG/ML

02 10.002MG/ML

03 10.004MG/ML

04 30.2MG/ML

05 10.4MG/ML (0.4MG/ML)

06 10.5MG/VIAL

07 21%

08 11.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)

09 11.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)

10 11.5GM/1.5ML (1GM/ML)

11 110%

12 1100% (10ML)

13 1100% (20ML)

14 1100% (5ML)

15 1100MG IRON/2ML (50MG IRON/ML)

16 1100MG/20ML (5MG/ML)

17 4100MG/ML

18 1100MG/VIAL

19 110MG/10ML (1MG/ML)

20 310MG/ML

21 110MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

22 110MG/VIAL

23 111.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)

24 113.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)

25 1160MG/ML

26 11GM IRON/20ML (50MG IRON/ML)

27 11GM/10ML (100MG/ML)

28 11MG/10ML (0.1MG/ML)

29 21MG/ML

30 11MG/ML (1MG/ML)

31 12.5MG/ML

32 120%

33 3200MG/ML

34 1200UNITS/10ML (20UNITS/ML)

35 120MG/2ML (10MG/ML)

36 220MG/ML

37 120UNITS/ML (20UNITS/ML)

38 125MG/10ML (2.5MG/ML)

39 325MG/ML

40 13.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)

41 130MG/10ML (3MG/ML)

42 13MG/ML

43 13MG/ML;EQ 3MG BASE/ML

44 14.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)

45 240MG/ML

46 14MG/2ML

47 1500MG IRON/10ML (50MG IRON/ML)

48 1500MG/5ML (100MG/ML)

49 1500MG/VIAL

50 150MG/10ML (5MG/ML)

51 250MG/5ML (10MG/ML)

52 550MG/ML

53 25MG/10ML (0.5MG/ML)

54 15MG/ML

55 16MG/ML

56 1750MG IRON/15ML (50MG IRON/ML)

57 180MG/ML

58 190MG/10ML (9MG/ML)

59 1EQ 0.3MG BASE/ML

60 1EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)

61 1EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)

62 1EQ 0.4MG COPPER/ML

63 1EQ 100MG IRON/5ML (EQ 20MG IRON/ML)

64 1EQ 10MG BASE/10ML (EQ 1MG BASE/ML)

65 1EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML)

66 1EQ 1GM BASE/VIAL

67 2EQ 1MG BASE/ML (EQ 1MG BASE/ML)

68 1EQ 2% BASE

69 1EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

70 1EQ 200MG BASE/VIAL

71 1EQ 200MG IRON/10ML (EQ 20MG IRON/ML)

72 1EQ 25MG BASE/5ML (EQ 5MG BASE/ML)

73 3EQ 2MG BASE/ML

74 1EQ 30MG BASE/10ML (EQ 3MG BASE/ML)

75 1EQ 30MG BASE/30ML (EQ 1MG BASE/ML)

76 2EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

77 2EQ 500MG BASE/VIAL

78 1EQ 50MG BASE/VIAL

79 1EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)

80 1EQ 50MG IRON/ML

81 2EQ 50MG PHENYTOIN NA/ML

82 1EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)

83 1EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)

84 1EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML)

85 1EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)

86 1EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)

filter Regulatory Info Reset all filters

113 All

01 54DISCN

02 58RX

03 1Blank

List of Suppliers

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01

Brand Name : ACETYLCYSTEINE

Pharma, Lab & Chemical Expo

Not Confirmed

Brand Name : ACETYLCYSTEINE

Pharma, Lab & Chemical Expo

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RLD : No

TE Code : AN

ACETYLCYSTEINE

American Regent

Dosage Form : SOLUTION; INHALATION, ORAL

Proprietary Name : ACETYLCYSTEINE

Dosage Strength : 10%

Approval Date : 1995-07-28

Application Number : 72489

RX/OTC/DISCN : RX

RLD : No

TE Code : AN

Product
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02

Brand Name : ACETYLCYSTEINE

Pharma, Lab & Chemical Expo

Not Confirmed

Brand Name : ACETYLCYSTEINE

Pharma, Lab & Chemical Expo

Not Confirmed

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Digital Content

RLD : No

TE Code : AN

ACETYLCYSTEINE

American Regent

Dosage Form : SOLUTION; INHALATION, ORAL

Proprietary Name : ACETYLCYSTEINE

Dosage Strength : 20%

Approval Date : 1995-07-28

Application Number : 72547

RX/OTC/DISCN : RX

RLD : No

TE Code : AN

Product
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03

Brand Name : ADENOSINE

Pharma, Lab & Chemical Expo

Not Confirmed

Brand Name : ADENOSINE

Pharma, Lab & Chemical Expo

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RLD : No

TE Code :

American Regent

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : ADENOSINE

Dosage Strength : 3MG/ML

Approval Date : 2009-04-28

Application Number : 90010

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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04

Brand Name : AMINOPHYLLINE

Pharma, Lab & Chemical Expo

Not Confirmed

Brand Name : AMINOPHYLLINE

Pharma, Lab & Chemical Expo

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RLD : No

TE Code :

AMINOPHYLLINE

American Regent

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : AMINOPHYLLINE

Dosage Strength : 25MG/ML

Approval Date : 1982-01-01

Application Number : 87600

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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05

Brand Name : ATROPINE SULFATE

Pharma, Lab & Chemical Expo

Not Confirmed

Brand Name : ATROPINE SULFATE

Pharma, Lab & Chemical Expo

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RLD : No

TE Code : AP

ATROPINE SULFATE

American Regent

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : ATROPINE SULFATE

Dosage Strength : 0.4MG/ML (0.4MG/ML)

Approval Date : 2022-05-26

Application Number : 216120

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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06

Brand Name : ATROPINE SULFATE

Pharma, Lab & Chemical Expo

Not Confirmed

Brand Name : ATROPINE SULFATE

Pharma, Lab & Chemical Expo

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Digital Content

RLD : No

TE Code : AP

ATROPINE SULFATE

American Regent

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : ATROPINE SULFATE

Dosage Strength : 1MG/ML (1MG/ML)

Approval Date : 2022-05-26

Application Number : 216120

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Product
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07

Brand Name : BETAMETHASONE ACETAT...

Pharma, Lab & Chemical Expo

Not Confirmed

Brand Name : BETAMETHASONE ACETAT...

Pharma, Lab & Chemical Expo

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RLD : No

TE Code : AB

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

American Regent

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : BETAMETHASONE ACETATE AN...

Dosage Strength : 3MG/ML;EQ 3MG BASE/ML

Approval Date : 2009-07-31

Application Number : 90747

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
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08

Brand Name : BUPRENORPHINE HYDROC...

Pharma, Lab & Chemical Expo

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Brand Name : BUPRENORPHINE HYDROC...

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RLD : No

TE Code :

BUPRENORPHINE HYDROCHLORIDE

American Regent

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : BUPRENORPHINE HYDROCHLOR...

Dosage Strength : EQ 0.3MG BASE/ML

Approval Date : 2007-03-27

Application Number : 78331

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

Brand Name : BUSULFAN

Pharma, Lab & Chemical Expo

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Brand Name : BUSULFAN

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RLD : No

TE Code :

American Regent

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : BUSULFAN

Dosage Strength : 6MG/ML

Approval Date : 2015-12-22

Application Number : 202259

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

Brand Name : CAFFEINE CITRATE

Pharma, Lab & Chemical Expo

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Brand Name : CAFFEINE CITRATE

Pharma, Lab & Chemical Expo

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RLD : No

TE Code : AP

CAFFEINE CITRATE

American Regent

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : CAFFEINE CITRATE

Dosage Strength : EQ 30MG BASE/3ML (EQ 10M...

Approval Date : 2007-05-15

Application Number : 77906

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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