Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200541
Company: LUPIN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG 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
06/25/2012 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
01/28/2019 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

01/28/2019 SUPPL-5 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

09/26/2012 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

NORGESTIMATE AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 203873 AMNEAL PHARMS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 204057 GLENMARK PHARMS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 200541 LUPIN PHARMS
ORTHO TRI-CYCLEN LO ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription Yes AB 021241 JANSSEN PHARMS
TRI LO SPRINTEC ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 076784 BARR LABS INC
TRI-LO-ESTARYLLA ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 091232 LABS LEON FARMA
TRI-LO-MILI ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 205762 AUROBINDO PHARMA LTD

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