Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075147
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 20MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/27/1998 ORIG-1 Approval Label
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.htm https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.htm https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2000 SUPPL-3 Labeling

Label is not available on this site.

03/20/2000 SUPPL-2 Labeling

Label is not available on this site.

09/23/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/27/1998 ORIG-1 Approval https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.htm

ISOSORBIDE MONONITRATE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 20MG TABLET;ORAL Prescription No AB 075037 ACTAVIS ELIZABETH
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 20MG TABLET;ORAL Prescription No AB 075147 ANI PHARMS INC
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 20MG TABLET;ORAL Prescription No AB 075361 HIKMA PHARMS
MONOKET ISOSORBIDE MONONITRATE 20MG TABLET;ORAL Prescription Yes AB 020215 LANNETT CO INC

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