Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090454
Company: GLENMARK PHARMS LTD

Products on ANDA 090454

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEATHER	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090454

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2010	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
03/29/2013	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.
12/03/2012	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090454

HEATHER

TABLET;ORAL-28; 0.35MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CAMILA	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	No	AB1	076177	DR REDDYS LABS SA
HEATHER	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	No	AB1	090454	GLENMARK PHARMS LTD
INCASSIA	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	No	AB1	207304	AUROBINDO PHARMA
NOR-QD	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	Yes	AB1	017060	TEVA BRANDED PHARM
NORETHINDRONE	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	No	AB1	091325	LUPIN LTD
NORETHINDRONE	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	No	AB1	206807	NAARI PTE LTD
NORETHINDRONE	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	No	AB1	202014	NOVAST LABS
NORETHINDRONE	NORETHINDRONE	0.35MG	TABLET;ORAL-28	Prescription	No	AB1	201483	XIROMED