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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091090
Company: GLENMARK PHARMS LTD

Products on ANDA 091090

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORETHINDRONE ACETATE	NORETHINDRONE ACETATE	5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091090

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/21/2010	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 091090

NORETHINDRONE ACETATE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NORETHINDRONE ACETATE	NORETHINDRONE ACETATE	5MG	TABLET;ORAL	Prescription	No	AB	200275	AMNEAL PHARMS
NORETHINDRONE ACETATE	NORETHINDRONE ACETATE	5MG	TABLET;ORAL	Prescription	No	AB	075951	BARR
NORETHINDRONE ACETATE	NORETHINDRONE ACETATE	5MG	TABLET;ORAL	Prescription	No	AB	091090	GLENMARK PHARMS LTD
NORETHINDRONE ACETATE	NORETHINDRONE ACETATE	5MG	TABLET;ORAL	Prescription	No	AB	205278	MYLAN LABS LTD
NORETHINDRONE ACETATE	NORETHINDRONE ACETATE	5MG	TABLET;ORAL	Prescription	No	AB	206490	NOVAST LABS

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