Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200490
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG 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
04/21/2015 ORIG-1 Approval Not Applicable

Label is not available on this site.

LEVONORGESTREL AND ETHINYL ESTRADIOL

TABLET;ORAL; 0.03MG;0.15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INTROVALE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 079064 SANDOZ
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 203871 AMNEAL PHARMS
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 203164 GLENMARK PHARMS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 091440 LUPIN LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 200490 MYLAN LABS LTD
QUASENSE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 077101 WATSON LABS
SEASONALE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription Yes AB 021544 TEVA BRANDED PHARM
SETLAKIN ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 090716 NOVAST LABS LTD

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