Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205630
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;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
10/27/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/14/2019 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

02/14/2019 SUPPL-3 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

NORGESTIMATE AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.035MG;0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTARYLLA ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG TABLET;ORAL-28 Prescription No AB 090794 LABS LEON FARMA
MILI ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG TABLET;ORAL-28 Prescription No AB 205449 AUROBINDO PHARMA LTD
MONO-LINYAH ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG TABLET;ORAL-28 Prescription No AB 090523 NOVAST LABS LTD
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG TABLET;ORAL-28 Prescription No AB 203865 AMNEAL PHARMS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG TABLET;ORAL-28 Prescription No AB 200538 GLENMARK GENERICS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG TABLET;ORAL-28 Prescription No AB 205630 LUPIN LTD
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG TABLET;ORAL-28 Prescription No AB 201896 MYLAN LABS LTD
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG TABLET;ORAL-28 Prescription No AB 200384 OC PHARMA
PREVIFEM ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG TABLET;ORAL-28 Prescription No AB 076334 VINTAGE PHARMS LLC
SPRINTEC ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG TABLET;ORAL-28 Prescription No AB 075804 BARR

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