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Bausch Health
FDA Orange Book

munit-sa-m-2025-04-14

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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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SPI Pharma has been solving formulation challenges using superior functional materials.

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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Suanfarma, at the Core of a Better Life.

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xyz-pharma-m-2025-04-14

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Bausch Health

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
Google Map, LinkedIn, Emails...

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 895 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
895 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

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

9 All APIs
5 USDMF
1 CEP/COS
3 KDMF

DEVELOPMENTS

21 Drugs in Development

21 Drugs in Development

FINISHED DOSAGE FORMULATIONS

283 FDF Dossiers, 145 FDA Orange Book, 11 Europe, 127 Canada

283 FDF Dossiers
145 FDA Orange Book
11 Europe
127 Canada

INSPECTIONS & REGISTRATIONS

22 FDA, 7 EDQM, 4 GDUFA

22 FDA
7 EDQM
4 GDUFA

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FILTER :

filter Active Ingredients Reset all filters

145 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 9TRETINOIN

62 1TRIOXSALEN

63 3VENLAFAXINE HYDROCHLORIDE

filter Dosage Reset all filters

145 All

01 24CAPSULE, EXTENDED RELEASE;ORAL

02 26CAPSULE;ORAL

03 10CREAM;TOPICAL

04 3FILM, EXTENDED RELEASE;TRANSDERMAL

05 3GEL;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

145 All

01 10.02%

02 10.025%

03 10.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML

04 10.025MG;2.5MG

05 50.05%

06 10.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

07 10.1%

08 20.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

09 10.1MG

10 10.1MG/HR

11 10.25MG

12 10.2MG/HR

13 10.3%

14 10.5%

15 10.6MG/HR

16 31%

17 21% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

18 11.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

19 6100MG

20 1100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

22 1105MG

23 710MG

24 210MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

25 3120MG

26 1120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

27 1120MG/5ML;12MG/5ML

28 3125MG

29 1125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

30 1145MG

31 115MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

32 2180MG

33 1180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

34 11MG

35 12%

36 22.5%

37 22.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

38 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

39 120%

40 3200MG

41 1200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

42 1210MG/1.5ML

43 2240MG

44 5250MG

45 1250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

46 525MG

47 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

48 125MG/ML

49 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

50 12MG/ML

51 3300MG

52 1300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

53 1300MG;30MG

54 330MG

55 130MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

56 1325MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

57 1325MG;50MG;40MG;30MG

58 135MG

59 1360MG

60 2400MG

61 1420MG

62 148MG

63 15%;3%

64 1500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

65 4500MG

66 450MG

67 65MG

68 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

69 360MG

70 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

71 1650MG;50MG

72 165MG

73 1750MG

74 175MG

75 18% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

76 290MG

77 190MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

78 1EQ 0.05MG BASE

79 1EQ 0.25MG BASE

80 1EQ 150MG BASE

81 1EQ 180MG HYDROCHLORIDE;5MG

82 2EQ 1MG BASE

83 1EQ 37.5MG BASE

84 1EQ 4MG MALEATE;EQ 5MG BITARTRATE

85 1EQ 75MG BASE

86 1EQ 8MG MALEATE;EQ 10MG BITARTRATE

filter Regulatory Info Reset all filters

145 All

01 112DISCN

02 31RX

03 2Blank

List of Suppliers

Supplier Virtual Booth

price-trend

01

Brand Name : PHRENILIN

MAGHREB PHARMA

Not Confirmed

Brand Name : PHRENILIN

MAGHREB PHARMA

Not Confirmed

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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
Web Link

Stock Recap
#PipelineProspector

02

Brand Name : PHRENILIN FORTE

MAGHREB PHARMA

Not Confirmed

Brand Name : PHRENILIN FORTE

MAGHREB PHARMA

Not Confirmed

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Digital Content

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
Web Link

Stock Recap
#PipelineProspector

03

Brand Name : PHRENILIN WITH CAFFE...

MAGHREB PHARMA

Not Confirmed

Brand Name : PHRENILIN WITH CAFFE...

MAGHREB PHARMA

Not Confirmed

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Digital Content

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
Web Link

Stock Recap
#PipelineProspector

04

Brand Name : ACETAMINOPHEN AND CO...

MAGHREB PHARMA

Not Confirmed

Brand Name : ACETAMINOPHEN AND CO...

MAGHREB PHARMA

Not Confirmed

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Digital Content

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
Web Link

Stock Recap
#PipelineProspector

05

Brand Name : CAPITAL AND CODEINE

MAGHREB PHARMA

Not Confirmed

Brand Name : CAPITAL AND CODEINE

MAGHREB PHARMA

Not Confirmed

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Digital Content

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
Web Link

Stock Recap
#PipelineProspector

06

Brand Name : AMINOPHYLLINE

MAGHREB PHARMA

Not Confirmed

Brand Name : AMINOPHYLLINE

MAGHREB PHARMA

Not Confirmed

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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
Web Link

Stock Recap
#PipelineProspector

07

Brand Name : DIPHENOXYLATE HYDROC...

MAGHREB PHARMA

Not Confirmed

Brand Name : DIPHENOXYLATE HYDROC...

MAGHREB PHARMA

Not Confirmed

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Digital Content

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
Web Link

Stock Recap
#PipelineProspector

08

Brand Name : NEO-POLYCIN

MAGHREB PHARMA

Not Confirmed

Brand Name : NEO-POLYCIN

MAGHREB PHARMA

Not Confirmed

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Digital Content

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
Web Link

Stock Recap
#PipelineProspector

09

Brand Name : COLAZAL

MAGHREB PHARMA

Not Confirmed

Brand Name : COLAZAL

MAGHREB PHARMA

Not Confirmed

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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

Product
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10

Brand Name : GIAZO

MAGHREB PHARMA

Not Confirmed

Brand Name : GIAZO

MAGHREB PHARMA

Not Confirmed

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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

TE Code :

Product
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Contact Bausch Health and get a quotation

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

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