Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076335
Company: VINTAGE PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRI-PREVIFEM ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;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
03/26/2004 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076335_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/24/2016 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

12/19/2014 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

02/24/2016 SUPPL-16 Labeling-Container/Carton Labels

Label is not available on this site.

01/03/2013 SUPPL-14 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

TRI-PREVIFEM

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

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