Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076675
Company: VINTAGE PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EMOQUETTE 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
02/25/2011 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
08/09/2017 SUPPL-11 Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/26/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

04/13/2015 SUPPL-6 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

02/27/2013 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

EMOQUETTE

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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