Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086034
Company: WATSON LABS

Products on ANDA 086034

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 086034

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/06/1988	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
12/10/1996	SUPPL-35	Labeling		Label is not available on this site.
02/17/1994	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
11/16/1992	SUPPL-33	Labeling		Label is not available on this site.
04/02/1992	SUPPL-32	Labeling		Label is not available on this site.
12/19/1991	SUPPL-31	Labeling		Label is not available on this site.
09/12/1991	SUPPL-30	Labeling		Label is not available on this site.
11/19/1990	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
08/07/1991	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
06/29/1990	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
06/13/1988	SUPPL-26	Labeling		Label is not available on this site.
03/29/1988	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
03/29/1988	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
03/29/1988	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
06/17/1985	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
02/25/1985	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.