Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074211
Company: ROXANE
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
02/28/1994 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
03/27/1997 SUPPL-5 Labeling

Label is not available on this site.

08/28/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/05/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/07/1996 SUPPL-2 Labeling

Label is not available on this site.

01/13/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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