Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200248
Company: LUPIN LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 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
11/19/2015 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
08/09/2017 SUPPL-3 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

LEVONORGESTREL AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ELIFEMME ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 202507 LABS LEON FARMA
ENPRESSE-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 075809 DURAMED PHARMS BARR
LEVONEST ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 090719 NOVAST LABS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 200248 LUPIN LTD
MYZILRA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 077502 VINTAGE PHARMS LLC
TRIVORA-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 074538 MAYNE PHARMA

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