Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084914
Company: SANDOZ

Products on ANDA 084914

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QUINIDINE SULFATE	QUINIDINE SULFATE	200MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084914

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/18/1977	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
06/10/1996	SUPPL-30	Labeling		Label is not available on this site.
04/26/1995	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
03/24/1989	SUPPL-28	Labeling		Label is not available on this site.
12/20/1988	SUPPL-27	Labeling		Label is not available on this site.
03/12/1985	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
06/01/1984	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
06/01/1984	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
11/08/1983	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
07/22/1983	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
09/30/1982	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
03/10/1982	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
03/10/1982	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
03/10/1982	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
03/10/1982	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
03/10/1982	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/10/1982	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.