Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200492
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 0.03MG,0.01MG;0.15MG,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
05/27/2015 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-5 Labeling-Package Insert, Labeling-Proprietary Name Change, Labeling-Container/Carton Labels

Label is not available on this site.

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

TABLET;ORAL; 0.03MG,0.01MG;0.15MG,N/A
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ASHLYNA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription No AB 203163 GLENMARK GENERICS
DAYSEE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription No AB 091467 LUPIN LTD
JAIMIESS ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription No AB 203770 LABS LEON FARMA
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription No AB 203872 AMNEAL PHARMS
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription No AB 078834 MAYNE PHARMA
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription No AB 200492 MYLAN LABS LTD
SEASONIQUE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription Yes AB 021840 TEVA BRANDED PHARM
SIMPESSE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription No AB 206851 AUROBINDO PHARMA LTD

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