Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086054
Company: HIKMA INTL PHARMS

Products on ANDA 086054

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	2.5MG	TABLET;SUBLINGUAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 086054

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/1987	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
07/01/2002	SUPPL-41	Labeling		Label is not available on this site.
04/03/2001	SUPPL-40	Manufacturing (CMC)-Control		Label is not available on this site.
10/31/2000	SUPPL-39	Labeling		Label is not available on this site.
10/01/1998	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
03/03/1997	SUPPL-37	Labeling		Label is not available on this site.
07/06/1994	SUPPL-36	Labeling		Label is not available on this site.
12/04/1992	SUPPL-35	Labeling		Label is not available on this site.
03/27/1991	SUPPL-34	Labeling		Label is not available on this site.
02/13/1991	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
06/16/1993	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
06/16/1993	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
06/16/1993	SUPPL-30	Labeling		Label is not available on this site.
07/18/1991	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
08/25/1988	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
08/24/1988	SUPPL-26	Labeling		Label is not available on this site.
08/25/1988	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
08/25/1988	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
01/07/1987	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
05/11/1984	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
08/10/1984	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
08/10/1984	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
07/23/1982	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
08/10/1982	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
08/10/1982	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.
03/10/1982	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/10/1982	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.