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01 3BAYER HEALTHCARE LLC

02 2SCHERING

03 1AVANTHI INC

04 1BIONPHARMA

05 1COPLEY PHARM

06 1DR REDDYS LABS LTD

07 1HERITAGE PHARMA

08 1ORGANON

09 1ORGANON LLC

10 1P AND L

11 2PERRIGO PHARMA INTL

12 1PIONEER PHARMS

13 1SANDOZ

14 4SCHERING PLOUGH

15 1SUN PHARM INDS LTD

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.

RLD : No

TE Code :

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Brand Name : DISOPHROL

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG;60MG

Approval Date : 1982-01-01

Application Number : 12394

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.

RLD : Yes

TE Code :

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Brand Name : CHLOR-TRIMETON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 8MG;120MG

Approval Date : 1982-01-01

Application Number : 18397

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.

RLD : No

TE Code :

AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE

Brand Name : TRINALIN

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1MG;120MG

Approval Date : 1982-03-23

Application Number : 18506

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.

RLD : Yes

TE Code :

LORATADINE; PSEUDOEPHEDRINE SULFATE

Brand Name : CLARITIN-D

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG;120MG

Approval Date : 2002-11-27

Application Number : 19670

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBayer AG manufactures innovative APIs and pharmaceutical formulations across diverse therapeutic areas.

RLD : Yes

TE Code :

LORATADINE; PSEUDOEPHEDRINE SULFATE

Brand Name : CLARITIN-D 24 HOUR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG;240MG

Approval Date : 2002-11-27

Application Number : 20470

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

Company Banner

06

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Brand Name : DRIXORAL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 6MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-09-13

Application Number : 13483

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Brand Name : DISOPHROL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 6MG;120MG

Approval Date : 1982-09-13

Application Number : 13483

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

PSEUDOEPHEDRINE SULFATE

Brand Name : AFRINOL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 120MG

Approval Date : 1982-01-01

Application Number : 18191

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

Brand Name : DRIXORAL PLUS

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG;3MG;60MG

Approval Date : 1987-05-22

Application Number : 19453

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

PEGS Boston Summit
Not Confirmed
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arrow
PEGS Boston Summit
Not Confirmed

DESLORATADINE; PSEUDOEPHEDRINE SULFATE

Brand Name : CLARINEX-D 12 HOUR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 2.5MG;120MG

Approval Date : 2006-02-01

Application Number : 21313

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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