Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070756
Company: HERITAGE PHARMA

Products on ANDA 070756

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070756

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/1986	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-33	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/23/2021	SUPPL-32	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
01/28/2008	SUPPL-28	Labeling		Label is not available on this site.
11/21/2006	SUPPL-23	Labeling		Label is not available on this site.
07/29/2002	SUPPL-18	Manufacturing (CMC)-Facility		Label is not available on this site.
09/12/2001	SUPPL-17	Manufacturing (CMC)-Facility		Label is not available on this site.
07/25/2000	SUPPL-16	Labeling		Label is not available on this site.
07/25/2000	SUPPL-15	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/28/2000	SUPPL-14	Manufacturing (CMC)-Facility		Label is not available on this site.
02/02/2000	SUPPL-13	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
11/05/1998	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
05/30/1997	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/01/1995	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/01/1995	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
11/01/1994	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/18/1991	SUPPL-7	Labeling		Label is not available on this site.
12/18/1990	SUPPL-6	Labeling		Label is not available on this site.
12/18/1990	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/18/1990	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/18/1990	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/30/1989	SUPPL-2	Labeling		Label is not available on this site.
05/13/1987	SUPPL-1	Labeling		Label is not available on this site.