Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206053
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,0.15MG; 0.025MG,0.15MG;0.03MG,0.15MG; 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
10/02/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

TABLET;ORAL; 0.02MG,0.15MG; 0.025MG,0.15MG;0.03MG,0.15MG; 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,0.15MG; 0.025MG,0.15MG;0.03MG,0.15MG; 0.01MG,N/A TABLET;ORAL Prescription No AB 206053 MYLAN LABS LTD

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