Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200494
Company: GLENMARK GENERICS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription AB No No
NORGESTIMATE; ETHINYL ESTRADIOL NORGESTIMATE; ETHINYL ESTRADIOL 0.215MG; 0.035MG TABLET; ORAL Prescription None No No
NORGESTIMATE; ETHINYL ESTRADIOL NORGESTIMATE; ETHINYL ESTRADIOL 0.25MG; 0.035MG TABLET; ORAL Prescription None 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
06/17/2011 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
04/28/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
03/28/2013 SUPPL-5 Labeling-Container/Carton Labels

Label is not available on this site.
06/28/2012 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

NORGESTIMATE AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.035MG,0.035MG,0.035MG;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 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 203870 AMNEAL PHARMS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 200494 GLENMARK GENERICS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 205588 LUPIN LTD
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 201897 MYLAN LABS LTD
ORTHO TRI-CYCLEN ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription Yes AB 019697 JANSSEN PHARMS
TRI-ESTARYLLA ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 090793 XIROMED
TRI-LINYAH ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 090524 NOVAST LABS LTD
TRI-MILI ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 205441 AUROBINDO PHARMA LTD
TRI-PREVIFEM ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 076335 VINTAGE PHARMS LLC
TRI-SPRINTEC ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 075808 BARR

NORGESTIMATE; ETHINYL ESTRADIOL

There are no Therapeutic Equivalents.

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