Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074190
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPROXEN NAPROXEN 25MG/ML SUSPENSION;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/30/1994 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/15/2019 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

11/15/2019 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

11/15/2019 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

08/24/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

11/07/2007 SUPPL-10 Labeling

Label is not available on this site.

09/25/2007 SUPPL-9 Labeling

Label is not available on this site.

08/14/2006 SUPPL-7 Labeling

Label is not available on this site.

04/28/2003 SUPPL-5 Labeling

Label is not available on this site.

05/24/2000 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/28/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/30/1997 SUPPL-2 Labeling

Label is not available on this site.

01/27/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

NAPROXEN

SUSPENSION;ORAL; 25MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAPROSYN NAPROXEN 25MG/ML SUSPENSION;ORAL Prescription Yes AB 018965 ATNAHS PHARMA US
NAPROXEN NAPROXEN 25MG/ML SUSPENSION;ORAL Prescription No AB 212705 AMNEAL
NAPROXEN NAPROXEN 25MG/ML SUSPENSION;ORAL Prescription No AB 074190 HIKMA
NAPROXEN NAPROXEN 25MG/ML SUSPENSION;ORAL Prescription No AB 211910 NOVITIUM PHARMA

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