Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074538
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIVORA-21 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-21 Discontinued None No No
TRIVORA-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/18/1997 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074538.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

04/03/2007 SUPPL-17 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/074538s017lbl.pdf
02/10/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/08/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/03/2007 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/074538s017lbl.pdf

TRIVORA-21

There are no Therapeutic Equivalents.

TRIVORA-28

TABLET;ORAL-28; 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ELIFEMME ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 202507 LABS LEON FARMA
ENPRESSE-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 075809 DURAMED PHARMS BARR
LEVONEST ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 090719 NOVAST LABS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 200248 LUPIN LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 202970 MYLAN LABS LTD
MYZILRA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 077502 VINTAGE PHARMS LLC
TRIVORA-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 074538 MAYNE PHARMA

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