Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202791
Company: GLENMARK GENERICS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.09MG 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
04/09/2015 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
06/16/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LEVONORGESTREL AND ETHINYL ESTRADIOL

TABLET;ORAL; 0.02MG;0.09MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOLISHALE ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.09MG TABLET;ORAL Prescription No AB 091692 NOVAST LABS
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.09MG TABLET;ORAL Prescription No AB 202791 GLENMARK GENERICS
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.09MG TABLET;ORAL Prescription No AB 079218 WATSON LABS

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