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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078515
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL 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
03/30/2009 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078515s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/078515Orig1s000correctedltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/06/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

10/06/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

07/02/2010 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

07/02/2010 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/30/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078515s000lbl.pdf

DROSPIRENONE AND ETHINYL ESTRADIOL

TABLET;ORAL; 3MG;0.02MG
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;0.02MG TABLET;ORAL Prescription No AB 078515 BARR
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 204296 GLENMARK PHARMS LTD
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 211944 HETERO LABS
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 203291 HLTHCARE
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 202594 MYLAN LABS LTD
DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 078833 WATSON LABS
LO-ZUMANDIMINE DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 209632 AUROBINDO PHARMA LTD
LORYNA DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 079221 XIROMED
MELAMISA DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 202016 NOVAST LABS
NIKKI DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription No AB 201661 LUPIN LTD
YAZ DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET;ORAL Prescription Yes AB 021676 BAYER HLTHCARE
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