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Bausch Health
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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Bausch Health

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 880 NEWS #PharmaBuzz

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

ACTIVE PHARMA INGREDIENTS

6 All APIs, 5 USDMF, 1 CEP/COS, 3 KDMF

6 All APIs
5 USDMF
1 CEP/COS
3 KDMF

DEVELOPMENTS

31 Drugs in Development

31 Drugs in Development

FINISHED DOSAGE FORMULATIONS

281 FDF Dossiers, 146 FDA Orange Book, 11 Europe, 124 Canada

281 FDF Dossiers
146 FDA Orange Book
11 Europe
124 Canada

INSPECTIONS & REGISTRATIONS

22 FDA, 7 EDQM, 4 GDUFA

22 FDA
7 EDQM
4 GDUFA

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filter Active Ingredients Reset all filters

146 All

01 2ACETAMINOPHEN; BUTALBITAL

02 1ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

03 2ACETAMINOPHEN; CODEINE PHOSPHATE

04 1AMINOPHYLLINE

05 1ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

06 1BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

07 2BALSALAZIDE DISODIUM

08 1BENZOYL PEROXIDE; ERYTHROMYCIN

09 1BEXAROTENE

10 1BRODALUMAB

11 1CARBIDOPA

12 4CHLORDIAZEPOXIDE

13 5CHLORDIAZEPOXIDE HYDROCHLORIDE

14 2CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

15 1CICLOPIROX

16 1DICLOFENAC SODIUM

17 18DILTIAZEM HYDROCHLORIDE

18 1DILTIAZEM MALATE; ENALAPRIL MALEATE

19 2DIPHENHYDRAMINE HYDROCHLORIDE

20 1ERYTHROMYCIN

21 2FENOFIBRATE

22 2FLUOXYMESTERONE

23 2FLURAZEPAM HYDROCHLORIDE

24 1FOLIC ACID

25 1GATIFLOXACIN

26 1GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

27 2GRISEOFULVIN, MICROCRYSTALLINE

28 2GRISEOFULVIN, MICROSIZE

29 9HYDROCORTISONE

30 1ISONIAZID

31 3ISOSORBIDE DINITRATE

32 3LEVODOPA

33 2LEVORPHANOL TARTRATE

34 2MEPROBAMATE

35 2METHOXSALEN

36 3METHYLTESTOSTERONE

37 1MINOCYCLINE HYDROCHLORIDE

38 1MONOBENZONE

39 5NIFEDIPINE

40 3NITROGLYCERIN

41 2PENICILLAMINE

42 1PENTOBARBITAL SODIUM

43 1PENTOXIFYLLINE

44 3PERGOLIDE MESYLATE

45 2PHENDIMETRAZINE TARTRATE

46 2PIPERACETAZINE

47 2PREDNICARBATE

48 1PREDNISOLONE

49 1PREDNISONE

50 2PRIMIDONE

51 1PROPOXYPHENE HYDROCHLORIDE

52 1QUINIDINE SULFATE

53 2RAUWOLFIA SERPENTINA ROOT

54 2RESERPINE

55 3SECOBARBITAL SODIUM

56 1SODIUM NITROPRUSSIDE

57 1SULFISOXAZOLE

58 2TETRACYCLINE HYDROCHLORIDE

59 2THEOPHYLLINE

60 3TRAMADOL HYDROCHLORIDE

61 10TRETINOIN

62 1TRIOXSALEN

63 3VENLAFAXINE HYDROCHLORIDE

filter Dosage Reset all filters

146 All

01 24CAPSULE, EXTENDED RELEASE;ORAL

02 26CAPSULE;ORAL

03 10CREAM;TOPICAL

04 3FILM, EXTENDED RELEASE;TRANSDERMAL

05 4GEL;TOPICAL

06 4INJECTABLE;INJECTION

07 7LOTION;TOPICAL

08 1OINTMENT;OPHTHALMIC

09 1OINTMENT;TOPICAL

10 1POWDER, EXTENDED RELEASE;DENTAL

11 1SOLUTION/DROPS;OPHTHALMIC

12 1SOLUTION; OPHTHALMIC

13 3SOLUTION;TOPICAL

14 2SUSPENSION;ORAL

15 1SWAB;TOPICAL

16 11TABLET, EXTENDED RELEASE;ORAL

17 1TABLET;BUCCAL

18 42TABLET;ORAL

19 3TABLET;SUBLINGUAL

filter Dosage Strength Reset all filters

146 All

01 10.01%

02 10.02%

03 10.025%

04 10.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML

05 10.025MG;2.5MG

06 50.05%

07 10.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

08 10.1%

09 20.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

10 10.1MG

11 10.1MG/HR

12 10.25MG

13 10.2MG/HR

14 10.3%

15 10.5%

16 10.6MG/HR

17 31%

18 21% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

19 11.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

20 6100MG

21 1100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

22 1100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

23 1105MG

24 710MG

25 210MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

26 3120MG

27 1120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

28 1120MG/5ML;12MG/5ML

29 3125MG

30 1125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

31 1145MG

32 115MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

33 2180MG

34 1180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

35 11MG

36 12%

37 22.5%

38 22.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

39 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

40 120%

41 3200MG

42 1200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

43 1210MG/1.5ML

44 2240MG

45 5250MG

46 1250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

47 525MG

48 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

49 125MG/ML

50 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

51 12MG/ML

52 3300MG

53 1300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

54 1300MG;30MG

55 330MG

56 130MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

57 1325MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

58 1325MG;50MG;40MG;30MG

59 135MG

60 1360MG

61 2400MG

62 1420MG

63 148MG

64 15%;3%

65 1500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

66 4500MG

67 450MG

68 65MG

69 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

70 360MG

71 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

72 1650MG;50MG

73 165MG

74 1750MG

75 175MG

76 18% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

77 290MG

78 190MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

79 1EQ 0.05MG BASE

80 1EQ 0.25MG BASE

81 1EQ 150MG BASE

82 1EQ 180MG HYDROCHLORIDE;5MG

83 2EQ 1MG BASE

84 1EQ 37.5MG BASE

85 1EQ 4MG MALEATE;EQ 5MG BITARTRATE

86 1EQ 75MG BASE

87 1EQ 8MG MALEATE;EQ 10MG BITARTRATE

filter Regulatory Info Reset all filters

146 All

01 112DISCN

02 32RX

03 2Blank

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01

Brand Name : PHRENILIN

Antibody Engineering

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Brand Name : PHRENILIN

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RLD : Yes

TE Code :

ACETAMINOPHEN; BUTALBITAL

Bausch Health

Dosage Form : TABLET; ORAL

Proprietary Name : PHRENILIN

Dosage Strength : 325MG;50MG **Federal Reg...

Approval Date : 1985-06-19

Application Number : 87811

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product
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02

Brand Name : PHRENILIN FORTE

Antibody Engineering

Not Confirmed

Brand Name : PHRENILIN FORTE

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RLD : No

TE Code :

ACETAMINOPHEN; BUTALBITAL

Bausch Health

Dosage Form : CAPSULE; ORAL

Proprietary Name : PHRENILIN FORTE

Dosage Strength : 650MG;50MG

Approval Date : 1985-06-19

Application Number : 88831

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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03

Brand Name : PHRENILIN WITH CAFFE...

Antibody Engineering

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Brand Name : PHRENILIN WITH CAFFE...

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RLD : No

TE Code :

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Bausch Health

Dosage Form : CAPSULE; ORAL

Proprietary Name : PHRENILIN WITH CAFFEINE ...

Dosage Strength : 325MG;50MG;40MG;30MG

Approval Date : 2001-08-22

Application Number : 74911

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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04

Brand Name : ACETAMINOPHEN AND CO...

Antibody Engineering

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Brand Name : ACETAMINOPHEN AND CO...

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RLD : No

TE Code :

ACETAMINOPHEN; CODEINE PHOSPHATE

Bausch Health

Dosage Form : TABLET; ORAL

Proprietary Name : ACETAMINOPHEN AND CODEIN...

Dosage Strength : 300MG;30MG

Approval Date : 1982-01-01

Application Number : 85896

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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05

Brand Name : CAPITAL AND CODEINE

Antibody Engineering

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Brand Name : CAPITAL AND CODEINE

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RLD : No

TE Code :

ACETAMINOPHEN; CODEINE PHOSPHATE

Bausch Health

Dosage Form : SUSPENSION; ORAL

Proprietary Name : CAPITAL AND CODEINE

Dosage Strength : 120MG/5ML;12MG/5ML

Approval Date : 1982-01-01

Application Number : 86024

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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06

Brand Name : AMINOPHYLLINE

Antibody Engineering

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Brand Name : AMINOPHYLLINE

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RLD : No

TE Code :

AMINOPHYLLINE

Bausch Health

Dosage Form : TABLET; ORAL

Proprietary Name : AMINOPHYLLINE

Dosage Strength : 200MG

Approval Date : 1982-01-01

Application Number : 84563

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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07

Brand Name : DIPHENOXYLATE HYDROC...

Antibody Engineering

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Brand Name : DIPHENOXYLATE HYDROC...

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RLD : No

TE Code :

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Bausch Health

Dosage Form : TABLET; ORAL

Proprietary Name : DIPHENOXYLATE HYDROCHLOR...

Dosage Strength : 0.025MG;2.5MG

Approval Date : 1982-02-16

Application Number : 87195

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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08

Brand Name : NEO-POLYCIN

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Brand Name : NEO-POLYCIN

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RLD : No

TE Code :

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Bausch Health

Dosage Form : OINTMENT; OPHTHALMIC

Proprietary Name : NEO-POLYCIN

Dosage Strength : 500 UNITS/GM;EQ 3.5MG BA...

Approval Date : 1982-01-01

Application Number : 60647

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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09

Brand Name : COLAZAL

Antibody Engineering

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Brand Name : COLAZAL

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RLD : Yes

TE Code : AB

BALSALAZIDE DISODIUM

Bausch Health

Dosage Form : CAPSULE; ORAL

Proprietary Name : COLAZAL

Dosage Strength : 750MG

Approval Date : 2000-07-18

Application Number : 20610

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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10

Brand Name : GIAZO

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Brand Name : GIAZO

Antibody Engineering

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RLD : Yes

TE Code :

BALSALAZIDE DISODIUM

Bausch Health

Dosage Form : TABLET; ORAL

Proprietary Name : GIAZO

Dosage Strength : 1.1GM **Federal Register...

Approval Date : 2012-02-03

Application Number : 22205

RX/OTC/DISCN : DISCN

RLD : Yes

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Contact Bausch Health and get a quotation

Bausch Health is a supplier offers 3 products (APIs, Excipients or Intermediates).

Find a price of Metformin bulk with DMF offered by Bausch Health

Find a price of Pyridostigmine bulk with DMF offered by Bausch Health

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