Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075337
Company: PLIVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPROXEN NAPROXEN 375MG TABLET, DELAYED RELEASE;ORAL Discontinued None No No
NAPROXEN NAPROXEN 500MG TABLET, DELAYED RELEASE;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
05/26/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75337ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/03/2006 SUPPL-9 Labeling

Label is not available on this site.

02/17/2006 SUPPL-5 Labeling

Label is not available on this site.

07/01/2002 SUPPL-4 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/01/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

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