Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075037
Company: ACTAVIS ELIZABETH
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
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 10MG 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
10/30/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75037ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/2000 SUPPL-2 Labeling

Label is not available on this site.

11/24/1999 SUPPL-1 Labeling

Label is not available on this site.

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

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 10MG TABLET;ORAL Prescription No AB 075037 ACTAVIS ELIZABETH
MONOKET ISOSORBIDE MONONITRATE 10MG TABLET;ORAL Prescription Yes AB 020215 LANNETT CO INC

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