Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087810
Company: ANI PHARMS

Products on ANDA 087810

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QUINIDINE GLUCONATE	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087810

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/1982	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
01/08/2001	SUPPL-21	Labeling		Label is not available on this site.
04/30/1999	SUPPL-20	Labeling		Label is not available on this site.
10/08/1998	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
07/16/1996	SUPPL-17	Labeling		Label is not available on this site.
04/14/1992	SUPPL-13	Labeling		Label is not available on this site.
01/10/1992	SUPPL-12	Labeling		Label is not available on this site.
07/02/1991	SUPPL-11	Labeling		Label is not available on this site.
08/12/1991	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/28/1991	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/07/1991	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/17/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/18/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/08/1983	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/01/1982	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.