Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071148
Company: ANI PHARMS

Products on ANDA 071148

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071148

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/18/1987	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
11/21/2024	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/17/2021	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/09/2016	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
08/13/2002	SUPPL-15	Labeling		Label is not available on this site.
06/05/2001	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
07/07/2000	SUPPL-13	Manufacturing (CMC)-Facility		Label is not available on this site.
07/02/1996	SUPPL-12	Labeling		Label is not available on this site.
04/29/1996	SUPPL-11	Labeling		Label is not available on this site.
07/15/1994	SUPPL-10	Labeling		Label is not available on this site.
05/11/1994	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/08/1991	SUPPL-7	Labeling		Label is not available on this site.
04/01/1991	SUPPL-6	Labeling		Label is not available on this site.
02/24/1989	SUPPL-5	Labeling		Label is not available on this site.
02/08/1989	SUPPL-4	Labeling		Label is not available on this site.
11/23/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.