Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087946
Company: PAR PHARM

Products on ANDA 087946

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	30MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087946

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/12/1987	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
05/24/2002	SUPPL-18	Labeling		Label is not available on this site.
12/07/1999	SUPPL-17	Labeling		Label is not available on this site.
06/23/1997	SUPPL-16	Labeling		Label is not available on this site.
07/11/1996	SUPPL-15	Labeling		Label is not available on this site.
11/01/1991	SUPPL-14	Labeling		Label is not available on this site.
03/16/1994	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/16/1994	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/04/1984	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 087946

ISOSORBIDE DINITRATE

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	30MG	TABLET;ORAL	Prescription	No	AB	087946	PAR PHARM
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	30MG	TABLET;ORAL	Prescription	No	AB	215723	RUBICON
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	30MG	TABLET;ORAL	Prescription	No	AB	213057	ZYDUS