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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080259
Company: ANI PHARMS

Products on ANDA 080259

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROMPT PHENYTOIN SODIUM	PHENYTOIN SODIUM	100MG PROMPT	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080259

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/1978	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
07/29/2002	SUPPL-49	Manufacturing (CMC)-Facility		Label is not available on this site.
03/12/2002	SUPPL-48	Manufacturing (CMC)-Facility		Label is not available on this site.
03/28/2000	SUPPL-47	Manufacturing (CMC)-Facility		Label is not available on this site.
01/28/2000	SUPPL-46	Manufacturing (CMC)-Facility		Label is not available on this site.
11/23/1999	SUPPL-45	Manufacturing (CMC)-Facility		Label is not available on this site.
08/20/1999	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
12/09/1998	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
05/30/1997	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
04/30/1993	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
02/23/1993	SUPPL-40	Manufacturing (CMC)		Label is not available on this site.
02/23/1993	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
07/17/1992	SUPPL-38	Labeling		Label is not available on this site.
08/07/1989	SUPPL-37	Labeling		Label is not available on this site.
06/26/1989	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
09/10/1987	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
09/10/1987	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
04/13/1987	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
04/13/1987	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
04/13/1987	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.

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