Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200493
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG,0.1MG;0.01MG,N/A 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
06/17/2015 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/24/2019 SUPPL-4 Labeling-Proprietary Name Change, Labeling-Container/Carton Labels

Label is not available on this site.

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

TABLET;ORAL; 0.02MG,0.1MG;0.01MG,N/A
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG,0.1MG;0.01MG,N/A TABLET;ORAL Prescription No AB 091674 LUPIN LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG,0.1MG;0.01MG,N/A TABLET;ORAL Prescription No AB 200407 MAYNE PHARMA
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG,0.1MG;0.01MG,N/A TABLET;ORAL Prescription No AB 200493 MYLAN LABS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG,0.1MG;0.01MG,N/A TABLET;ORAL Prescription No AB 205131 XIROMED
LO SIMPESSE ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG,0.1MG;0.01MG,N/A TABLET;ORAL Prescription No AB 206852 AUROBINDO PHARMA LTD
LOSEASONIQUE ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG,0.1MG;0.01MG,N/A TABLET;ORAL Prescription No AB 022262 TEVA BRANDED PHARM

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