Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074129
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPROXEN NAPROXEN 250MG TABLET;ORAL Discontinued None No No
NAPROXEN NAPROXEN 375MG TABLET;ORAL Discontinued None No No
NAPROXEN NAPROXEN 500MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/21/1993 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
09/27/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

09/18/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/18/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/18/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/14/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/14/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/14/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/24/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/05/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/05/1996 SUPPL-2 Labeling

Label is not available on this site.

03/05/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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