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

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01 2DR REDDYS

02 3GRANULES

03 2ACTAVIS ELIZABETH

04 2ACTAVIS LABS FL INC

05 2AJANTA PHARMA LTD

06 1AMNEAL

07 3AMNEAL PHARMS NY

08 6ATNAHS PHARMA US

09 3AUROBINDO PHARMA

10 2AUROBINDO PHARMA USA

11 3CHARTWELL MOLECULES

12 3DAVA PHARMS INC

13 2DR REDDYS LABS LTD

14 2FOSUN PHARMA

15 3GLENMARK PHARMS LTD

16 3HAMILTON PHARMS

17 1HETERO LABS LTD III

18 1HIKMA

19 3HIKMA INTL PHARMS

20 2HORIZON

21 3INVAGEN PHARMS

22 3IVAX SUB TEVA PHARMS

23 3L PERRIGO CO

24 3MARKSANS PHARMA

25 2MYLAN

26 3NORVIUM BIOSCIENCE

27 3NOVITIUM PHARMA

28 2NUVO PHARMS INC

29 5PLIVA

30 3PUREPAC PHARM

31 3ROXANE

32 5SCIEGEN PHARMS INC

33 3TAKEDA PHARMS NA

34 11TEVA

35 3TEVA PHARMS

36 2TULEX PHARMS INC

37 3WATSON LABS

38 3WATSON LABS TEVA

39 3ZYDUS PHARMS USA

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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 : AB

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Brand Name : NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : EQ 20MG BASE;375MG

Approval Date : 2020-02-18

Application Number : 204206

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

02

  • 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 : AB

NAPROXEN

Brand Name : NAPROXEN

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG

Approval Date : 1993-12-21

Application Number : 74140

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

03

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code : AB

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Brand Name : NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : EQ 20MG BASE;500MG

Approval Date : 2020-02-18

Application Number : 204206

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

04

  • 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 : AB

NAPROXEN

Brand Name : NAPROXEN

Dosage Form : TABLET;ORAL

Dosage Strength : 375MG

Approval Date : 1993-12-21

Application Number : 74140

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

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 : AB

NAPROXEN

Brand Name : NAPROXEN

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 1993-12-21

Application Number : 74140

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

06

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NAPROXEN

Brand Name : NAPROSYN

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG

Approval Date : 1982-01-01

Application Number : 17581

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

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NAPROXEN

Brand Name : NAPROSYN

Dosage Form : TABLET;ORAL

Dosage Strength : 375MG

Approval Date : 1982-01-01

Application Number : 17581

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

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NAPROXEN

Brand Name : NAPROSYN

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 1982-04-15

Application Number : 17581

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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09

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NAPROXEN

Brand Name : NAPROSYN

Dosage Form : SUSPENSION;ORAL

Dosage Strength : 25MG/ML

Approval Date : 1987-03-23

Application Number : 18965

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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10

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NAPROXEN

Brand Name : EC-NAPROSYN

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 375MG

Approval Date : 1994-10-14

Application Number : 20067

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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