Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074936
Company: ACTAVIS ELIZABETH
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
02/24/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74936ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74936ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74936.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/24/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74936ap_appltr_prntlbl_chemr.pdf

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