Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201887
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ENSKYCE DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription AB 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
03/07/2013 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
08/09/2017 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/02/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

06/19/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

04/01/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

ENSKYCE

TABLET;ORAL-28; 0.15MG;0.03MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESOGEN DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 020071 ORGANON USA INC
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 075256 DURAMED PHARMS BARR
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 202085 MYLAN LABS LTD
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 091234 NOVAST LABS LTD
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 076915 WATSON LABS
EMOQUETTE DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 076675 VINTAGE PHARMS LLC
ENSKYCE DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 201887 LUPIN LTD
ISIBLOOM DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 202789 SANDOZ INC
KALLIGA DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET;ORAL-28 Prescription No AB 207081 AUROBINDO PHARMA LTD

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