Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075155
Company: LANNETT CO INC
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
ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No Yes
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/1998/75155ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/24/2014 SUPPL-34 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075155Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/075155Orig1s034ltr.pdf
11/09/2004 SUPPL-28 Labeling

Label is not available on this site.

01/26/2001 SUPPL-20 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/30/2000 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/04/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/2000 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

12/14/1999 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

08/04/2000 SUPPL-13 Labeling

Label is not available on this site.

08/04/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/04/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/04/2000 SUPPL-10 Manufacturing (CMC)-New Strength

Label is not available on this site.

07/27/1999 SUPPL-8 Labeling

Label is not available on this site.

07/27/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/27/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/13/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/13/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/13/2000 SUPPL-3 Labeling

Label is not available on this site.

01/13/2000 SUPPL-2 Manufacturing (CMC)-New Strength

Label is not available on this site.

05/14/1999 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
09/24/2014 SUPPL-34 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075155Orig1s034lbl.pdf
09/24/2014 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075155Orig1s034lbl.pdf

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

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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