Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071448
Company: SUN PHARM INDUSTRIES

Products on ANDA 071448

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN	IBUPROFEN	800MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071448

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/18/1987	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
04/30/2021	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/22/2019	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/01/1998	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
08/12/1991	SUPPL-10	Labeling		Label is not available on this site.
09/20/1989	SUPPL-8	Labeling		Label is not available on this site.
07/12/1989	SUPPL-7	Labeling		Label is not available on this site.
12/16/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/11/1988	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/11/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/25/1987	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.