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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077527
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;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
05/09/2008 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077527s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/09/2015 SUPPL-3 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

10/09/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

DROSPIRENONE AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 3MG;0.03MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 077527 BARR
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 204848 GLENMARK PHARMS LTD
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 213034 HETERO LABS
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 201663 LUPIN LTD
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 090081 MAYNE PHARMA
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 202131 MYLAN LABS LTD
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 207245 NAARI PTE LTD
SYEDA DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 090114 XIROMED
YAELA DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 202015 NOVAST LABS
YASMIN DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription Yes AB 021098 BAYER HLTHCARE
ZUMANDIMINE DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET;ORAL-28 Prescription No AB 209407 AUROBINDO PHARMA LTD
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