Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075395
Company: NESHER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 120MG 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
03/16/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75395ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2015 SUPPL-25 Labeling

Label is not available on this site.

10/31/2007 SUPPL-18 Labeling

Label is not available on this site.

06/14/2007 SUPPL-13 Labeling

Label is not available on this site.

06/14/2007 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/09/2002 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/09/2002 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

08/23/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/2000 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

ISOSORBIDE MONONITRATE

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

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; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210822 DEXCEL LTD
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075155 LANNETT CO INC
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075395 NESHER PHARMS
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210918 RICONPHARMA LLC
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200495 TORRENT PHARMS
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090598 VINTAGE PHARMS

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