Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076784
Company: BARR LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRI LO SPRINTEC 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
06/29/2009 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076784s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/19/2016 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

11/26/2012 SUPPL-5 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

TRI LO SPRINTEC

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 XIROMED
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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