Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071230
Company: VINTAGE PHARMS

Products on ANDA 071230

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN	IBUPROFEN	300MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071230

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/22/1986	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
04/28/2021	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
07/22/2019	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
12/05/1997	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
02/24/1997	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/22/1995	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
01/12/1994	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
06/02/1992	SUPPL-10	Labeling		Label is not available on this site.
12/14/1992	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
06/28/1989	SUPPL-8	Labeling		Label is not available on this site.
12/30/1988	SUPPL-6	Labeling		Label is not available on this site.
01/13/1989	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/11/1988	SUPPL-4	Labeling		Label is not available on this site.
01/13/1989	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/27/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/17/1987	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.