Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089773
Company: BAUSCH

Products on ANDA 089773

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MINITRAN	NITROGLYCERIN	0.4MG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089773

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/1996	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
08/13/2001	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
01/18/2000	SUPPL-26	Labeling		Label is not available on this site.
06/11/1999	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
06/16/1998	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
12/21/1995	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
08/30/1996	SUPPL-22	Labeling		Label is not available on this site.
08/30/1996	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
09/23/1994	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
09/24/1993	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
02/01/1993	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
09/11/1992	SUPPL-12	Bioequivalence		Label is not available on this site.
02/25/1992	SUPPL-11	Bioequivalence		Label is not available on this site.
03/30/1992	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/22/1991	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/22/1991	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/28/1988	SUPPL-1	Labeling		Label is not available on this site.