Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074936
Company: ACTAVIS ELIZABETH

Products on ANDA 074936

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074936

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.

Labels for ANDA 074936

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