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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075147
Company: ANI PHARMS

Products on ANDA 075147

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 075147

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/1998	ORIG-1	Approval			Label Letter Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.htm https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.htm https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2000	SUPPL-3	Labeling		Label is not available on this site.
03/20/2000	SUPPL-2	Labeling		Label is not available on this site.
09/23/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 075147

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/27/1998	ORIG-1	Approval			https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.htm

Therapeutic Equivalents for ANDA 075147

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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