Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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

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 040591 HIKMA INTL PHARMS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 30MG TABLET;ORAL Prescription No AB 087946 PAR PHARM

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English