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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075037
Company: GENUS

Products on ANDA 075037

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	20MG	TABLET;ORAL	Prescription	AB	No	No
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075037

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/1998/75037ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
04/17/2000	SUPPL-2	Labeling		Label is not available on this site.
11/24/1999	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075037

ISOSORBIDE MONONITRATE

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	075147	ANI PHARMS
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	075147	ANI PHARMS
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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