Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091209
Company: GLENMARK PHARMS LTD

Products on ANDA 091209

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORETHINDRONE	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091209

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/22/2010	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2023	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/14/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
03/29/2013	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
07/31/2012	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091209

NORETHINDRONE

TABLET;ORAL-28; 0.35MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EMZAHH	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	No	AB2	216796	AUROBINDO PHARMA
ERRIN	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	No	AB2	076225	DR REDDYS LABS SA
JENCYCLA	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	No	AB2	091323	LUPIN LTD
NORETHINDRONE	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	No	AB2	091209	GLENMARK PHARMS LTD
NORETHINDRONE	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	No	AB2	200980	MYLAN LABS LTD
NORETHINDRONE	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	No	AB2	200961	NOVAST LABS