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

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01 2DR REDDYS LABS INC

02 1STRIDES PHARMA

03 1GRANULES

04 1GRANULES INDIA

05 2ABLE

06 3ACTAVIS LABS FL INC

07 1AMNEAL PHARMS CO

08 3AMNEAL PHARMS NY

09 2ATNAHS PHARMA US

10 1AUROBINDO PHARMA

11 4AUROBINDO PHARMA LTD

12 2BAYER

13 1BAYER HLTHCARE

14 1BIONPHARMA

15 1CATALENT

16 2CONTRACT PHARMACAL

17 1COREPHARMA

18 2CURRAX

19 3DR REDDYS LABS LTD

20 2GLENMARK PHARMS LTD

21 2HAMILTON PHARMS

22 1HETERO LABS LTD V

23 2HIKMA

24 2IVAX SUB TEVA PHARMS

25 1LNK INTL INC

26 1MARKSANS PHARMA

27 2NORVIUM BIOSCIENCE

28 1NOVELGENIX THERAPS

29 1P AND L

30 1PAR PHARM

31 1PATHEON SOFTGELS

32 2PERRIGO

33 1PERRIGO R AND D

34 1PLD ACQUISITIONS LLC

35 2PLIVA

36 1PURACAP PHARM LLC

37 2PUREPAC PHARM

38 1RISING PHARMA

39 2ROXANE

40 4SANDOZ

41 2SCIEGEN PHARMS INC

42 1SUN PHARM

43 1SUN PHARM INDS LTD

44 4TEVA

45 2TEVA PHARMS

46 3TWI PHARMS

47 4WATSON LABS

48 1YICHANG HUMANWELL

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PharmaCompass

01

  • 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

Brand Name : NAPROXEN SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 220MG

Approval Date : 1998-07-28

Application Number : 75168

RX/OTC/DISCN : OTC

RLD : No

TE Code :

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code :

NAPROXEN SODIUM

Brand Name : NAPROXEN SODIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 200MG BASE

Approval Date : 2022-08-17

Application Number : 215472

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

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 :

NAPROXEN SODIUM

Brand Name : NAPROXEN SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 220MG

Approval Date : 2011-09-20

Application Number : 91353

RX/OTC/DISCN : OTC

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

RLD : No

TE Code :

DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

Brand Name : NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG;220MG

Approval Date : 2020-09-24

Application Number : 213663

RX/OTC/DISCN : OTC

RLD : No

TE Code :

Granules India

06

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

NAPROXEN SODIUM

Brand Name : ANAPROX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 18164

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

NAPROXEN SODIUM

Brand Name : ANAPROX DS

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 500MG BASE

Approval Date : 1987-09-30

Application Number : 18164

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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08

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

NAPROXEN SODIUM

Brand Name : ALEVE

Dosage Form : TABLET;ORAL

Dosage Strength : 220MG

Approval Date : 1994-01-11

Application Number : 20204

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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09

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

NAPROXEN SODIUM

Brand Name : NAPRELAN

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 375MG BASE

Approval Date : 1996-01-05

Application Number : 20353

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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10

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

NAPROXEN SODIUM

Brand Name : NAPRELAN

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 500MG BASE

Approval Date : 1996-01-05

Application Number : 20353

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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