Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075522
Company: DEXCEL LTD
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
04/17/2000 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75522ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-522_Isosorbide%20Mononitrate.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2014 SUPPL-12 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

04/29/2011 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

03/24/2004 SUPPL-9 Labeling

Label is not available on this site.

02/19/2002 SUPPL-8 Labeling

Label is not available on this site.

02/19/2002 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/26/2001 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/04/2001 SUPPL-5 Labeling

Label is not available on this site.

04/04/2001 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/22/2000 SUPPL-3 Labeling

Label is not available on this site.

01/08/2001 SUPPL-1 Manufacturing (CMC)-Control

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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