Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077681
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 AB2 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
05/31/2006 ORIG-1 Approval Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/077681Orig1s000Lbl.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/14/2017 SUPPL-12 Labeling-Package Insert, Labeling-Patient 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
05/31/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/077681Orig1s000Lbl.pdf

LEVONORGESTREL AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.02MG;0.1MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LESSINA-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB2 075803 BARR
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB2 077681 MAYNE PHARMA
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB2 202247 MYLAN LABS LTD

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