Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076625
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription AB1 No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/18/2004 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-14 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

07/30/2012 SUPPL-10 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/076625Orig1s10Lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/30/2012 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/076625Orig1s10Lbl.pdf
07/30/2012 SUPPL-10 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/076625Orig1s10Lbl.pdf

LEVONORGESTREL AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.02MG;0.1MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AFIRMELLE ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB1 206886 AUROBINDO PHARMA LTD
AVIANE-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB1 075796 DURAMED PHARMS BARR
FALMINA ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB1 090721 NOVAST LABS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB1 201108 AMNEAL PHARMS
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB1 091425 LUPIN LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB1 076625 MAYNE PHARMA
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB1 200245 MYLAN LABS LTD
ORSYTHIA ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB1 077099 VINTAGE PHARMS LLC
VIENVA ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB1 201088 SANDOZ INC

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