Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074162
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPROXEN SODIUM NAPROXEN SODIUM EQ 250MG BASE TABLET;ORAL Discontinued None No No
NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG 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
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
04/19/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/29/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-8 Labeling

Label is not available on this site.

03/04/1999 SUPPL-7 Labeling

Label is not available on this site.

03/04/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/10/1997 SUPPL-5 Labeling

Label is not available on this site.

02/04/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/17/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/17/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/27/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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