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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020215
Company: OMNIVIUM PHARMS

Products on NDA 020215

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020215

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
02/01/2022	SUPPL-27	Manufacturing (CMC)-Facility	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020215Orig1s027Correctedltr.pdf
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.

Labels for NDA 020215

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

Therapeutic Equivalents for NDA 020215

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	GENUS
MONOKET	ISOSORBIDE MONONITRATE	20MG	TABLET;ORAL	Prescription	Yes	AB	020215	OMNIVIUM 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	GENUS
MONOKET	ISOSORBIDE MONONITRATE	10MG	TABLET;ORAL	Prescription	Yes	AB	020215	OMNIVIUM PHARMS

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