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Approved Drug Products containing Novafed listed in the FDA Orange Book. Original Data : FDA Website

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01 1SANOFI AVENTIS US

02 4DR REDDYS

03 1DR REDDYS LABS INC

04 1DR REDDYS LABS SA

05 1TARO

06 2GRANULES

07 1ACELLA

08 2ACTAVIS LABS FL

09 1ALKEM LABS LTD

10 1ALPHARMA US PHARMS

11 1ALZA

12 1ANIMA

13 2APOZEAL PHARMS

14 4AUROBINDO PHARMA

15 4AUROBINDO PHARMA LTD

16 1BARR

17 1BAYER

18 1BIONPHARMA

19 3CENCI

20 1CENT PHARMS

21 1CHARTWELL MOLECULAR

22 2CHARTWELL RX

23 2CHATTEM SANOFI

24 1CONTRACT PHARMACAL

25 2DR REDDYS LABS LTD

26 1ENDO OPERATIONS

27 1FISONS

28 3GLAXOSMITHKLINE

29 2GRAHAM DM

30 5HALEON US HOLDINGS

31 1IMPAX PHARMS

32 2IVAX SUB TEVA PHARMS

33 4J AND J CONSUMER INC

34 3KV PHARM

35 3L PERRIGO CO

36 2MAYNE PHARMA INC

37 1MCNEIL CONS

38 1MYLAN

39 2NEWTRON PHARMS

40 1NOVARTIS

41 1OHM LABS

42 3PADAGIS US

43 1PARKE DAVIS

44 2PERRIGO

45 2PERSION

46 1PHARM ASSOC

47 1PLD ACQUISITIONS

48 1PLD ACQUISITIONS LLC

49 1PPI-DAC

50 1PVT FORM

51 2RB HLTH

52 1RHODES PHARMS

53 1ROBINS AH

54 1SANDOZ

55 1SCHWARZ PHARMA

56 1SUN PHARM

57 2SUN PHARM INDS INC

58 2SUN PHARM INDS LTD

59 1SUPERPHARM

60 1TEVA

61 2TRIS PHARMA INC

62 1UNICHEM

63 1USL PHARMA

64 1WATSON LABS

65 1WES PHARMA INC

66 1WEST WARD

67 3WOCKHARDT

68 1WOCKHARDT BIO AG

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : No

TE Code :

PSEUDOEPHEDRINE HYDROCHLORIDE

Brand Name : NOVAFED

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 120MG

Approval Date : 1982-01-01

Application Number : 17603

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code :

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Brand Name : FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 60MG;120MG

Approval Date : 2014-11-18

Application Number : 76667

RX/OTC/DISCN : OTC

RLD : No

TE Code :

Dr Reddy Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code :

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Brand Name : GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 600MG;60MG

Approval Date : 2022-08-22

Application Number : 216082

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Granules India

04

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code :

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

Brand Name : NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 220MG;120MG

Approval Date : 2006-09-27

Application Number : 77381

RX/OTC/DISCN : OTC

RLD : No

TE Code :

Dr Reddy Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code : AA

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Brand Name : BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Dosage Form : SYRUP;ORAL

Dosage Strength : 2MG/5ML;10MG/5ML;30MG/5ML

Approval Date : 2018-12-04

Application Number : 207676

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Dr Reddy Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code :

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Brand Name : GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 600MG;60MG

Approval Date : 2017-12-29

Application Number : 208369

RX/OTC/DISCN : OTC

RLD : No

TE Code :

Dr Reddy Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code :

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Brand Name : GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1.2GM;120MG

Approval Date : 2017-12-29

Application Number : 208369

RX/OTC/DISCN : OTC

RLD : No

TE Code :

Dr Reddy Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code :

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Brand Name : FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 60MG;120MG

Approval Date : 2022-05-31

Application Number : 215434

RX/OTC/DISCN : OTC

RLD : No

TE Code :

Dr Reddy Company Banner

09

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Not Confirmed

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Brand Name : BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Dosage Form : SYRUP;ORAL

Dosage Strength : 2MG/5ML;10MG/5ML;30MG/5ML

Approval Date : 2017-02-27

Application Number : 205112

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

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10

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code :

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Brand Name : GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1.2GM;120MG

Approval Date : 2022-08-22

Application Number : 216082

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Granules India