Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091636
Company: GLENMARK GENERICS
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
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
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.

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 GENERICS
CYCLAFEM 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription No AB 076338 VINTAGE PHARMS LLC
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 LTD
ORTHO-NOVUM 7/7/7-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription Yes AB 018985 JANSSEN PHARMS
PIRMELLA 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription No AB 201510 LUPIN LTD

ALYACEN 777

There are no Therapeutic Equivalents.

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