Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021840
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SEASONIQUE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription AB Yes 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
05/25/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021840lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021840s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021840s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021840s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021840Orig1s011ltr.pdf
09/22/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/29/2010 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021840s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021840s008ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021840s011lbl.pdf
07/29/2010 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021840s008lbl.pdf
05/25/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021840lbl.pdf

SEASONIQUE

TABLET;ORAL; 0.03MG,0.01MG;0.15MG,N/A
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ASHLYNA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription No AB 203163 GLENMARK GENERICS
DAYSEE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription No AB 091467 LUPIN LTD
JAIMIESS ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription No AB 203770 XIROMED
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription No AB 203872 AMNEAL PHARMS
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription No AB 078834 MAYNE PHARMA
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription No AB 200492 MYLAN LABS LTD
SEASONIQUE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription Yes AB 021840 TEVA BRANDED PHARM
SIMPESSE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET;ORAL Prescription No AB 206851 AUROBINDO PHARMA LTD

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