Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074480
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG BASE TABLET;ORAL Discontinued None No No
NAPROXEN SODIUM NAPROXEN SODIUM EQ 250MG BASE 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
05/14/1996 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
09/08/2008 SUPPL-27 Labeling

Label is not available on this site.

05/08/2008 SUPPL-24 Labeling

Label is not available on this site.

10/16/2007 SUPPL-23 Labeling

Label is not available on this site.

10/05/2006 SUPPL-22 Labeling

Label is not available on this site.

06/07/2006 SUPPL-21 Labeling

Label is not available on this site.

06/09/2005 SUPPL-17 Labeling

Label is not available on this site.

04/09/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/01/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/18/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/18/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/18/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/18/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/18/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/18/1998 SUPPL-7 Labeling

Label is not available on this site.

02/18/1998 SUPPL-6 Manufacturing (CMC)-New Strength

Label is not available on this site.

03/14/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/06/1998 SUPPL-4 Labeling

Label is not available on this site.

03/06/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/06/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/06/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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