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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091636
Company: GLENMARK PHARMS LTD

Products on ANDA 091636

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALYACEN 7/7/7	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET;ORAL-28	Prescription	AB	No	No
ALYACEN 777	NORETHINDRONE; ETHINYL ESTRADIOL	0.75MG; 0.035MG	TABLET; ORAL	Prescription	None	No	No
ALYACEN 777	NORETHINDRONE; ETHINYL ESTRADIOL	1MG; 0.035MG	TABLET; ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091636

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/19/2012	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/06/2020	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/06/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
05/16/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
03/29/2013	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.
06/28/2012	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091636

ALYACEN 7/7/7

TABLET;ORAL-28; 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALYACEN 7/7/7	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET;ORAL-28	Prescription	No	AB	091636	GLENMARK PHARMS LTD
DASETTA 7/7/7	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET;ORAL-28	Prescription	No	AB	090946	NOVAST LABS LTD
NORTREL 7/7/7	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET;ORAL-28	Prescription	No	AB	075478	BARR
NYLIA 7/7/7	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET;ORAL-28	Prescription	No	AB	207054	AUROBINDO PHARMA

ALYACEN 777

There are no Therapeutic Equivalents.

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