Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020215
Company: KREMERS URBAN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MONOKET ISOSORBIDE MONONITRATE 20MG TABLET;ORAL Prescription AB Yes Yes
MONOKET ISOSORBIDE MONONITRATE 10MG TABLET;ORAL Prescription AB Yes 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
06/30/1993 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/02/2014 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020215Orig1s024ltr.pdf
05/15/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/19/2000 SUPPL-11 Labeling

Label is not available on this site.

10/26/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/29/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/13/1999 SUPPL-8 Labeling

Label is not available on this site.

08/07/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/25/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/20/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/12/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/02/1994 SUPPL-2 Labeling

Label is not available on this site.

12/15/1993 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/02/2014 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.pdf

MONOKET

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 KREMERS URBAN PHARMS

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 KREMERS URBAN PHARMS

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