Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088922
Company: ANI PHARMS

Products on ANDA 088922

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORPROPAMIDE	CHLORPROPAMIDE	250MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088922

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/12/1985	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
08/04/2003	SUPPL-21	Labeling		Label is not available on this site.
08/09/2001	SUPPL-20	Labeling		Label is not available on this site.
05/29/2001	SUPPL-19	Manufacturing (CMC)-Facility		Label is not available on this site.
06/20/2001	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
01/19/2001	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
07/07/2000	SUPPL-16	Manufacturing (CMC)-Facility		Label is not available on this site.
04/22/1994	SUPPL-15	Labeling		Label is not available on this site.
05/11/1994	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
02/25/1993	SUPPL-13	Labeling		Label is not available on this site.
07/29/1992	SUPPL-12	Labeling		Label is not available on this site.
03/24/1992	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
05/29/1991	SUPPL-10	Labeling		Label is not available on this site.
11/17/1988	SUPPL-9	Labeling		Label is not available on this site.
06/17/1987	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/30/1986	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.