Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074121
Company: MYLAN

Products on ANDA 074121

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074121

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
03/19/2020	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
03/19/2020	SUPPL-23	Labeling-Medication Guide		Label is not available on this site.
03/19/2020	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
07/25/2008	SUPPL-19	Labeling		Label is not available on this site.
06/07/2006	SUPPL-14	Labeling		Label is not available on this site.
11/01/1999	SUPPL-11	Manufacturing (CMC)-Facility		Label is not available on this site.
04/22/1999	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/07/1998	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/05/1998	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/06/1997	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/04/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/13/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/16/1996	SUPPL-4	Labeling		Label is not available on this site.
12/15/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/23/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.