Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076813
Company: HIKMA INTL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 30MG TABLET, EXTENDED RELEASE;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
01/07/2005 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
11/30/2015 SUPPL-12 Labeling-Container/Carton Labels

Label is not available on this site.

03/30/2006 SUPPL-2 Labeling

Label is not available on this site.

03/30/2006 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

ISOSORBIDE MONONITRATE

TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075522 DEXCEL LTD
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076813 HIKMA INTL PHARMS
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075155 LANNETT CO INC
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075395 NESHER PHARMS
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210918 RICONPHARMA LLC
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200495 TORRENT PHARMS
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090598 VINTAGE PHARMS

TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075522 DEXCEL LTD
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076813 HIKMA INTL PHARMS
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075155 LANNETT CO INC
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075395 NESHER PHARMS
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210918 RICONPHARMA LLC
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200270 TORRENT PHARMS
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090598 VINTAGE PHARMS

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