Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021544
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SEASONALE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG 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
09/05/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21544_seasonale_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21544ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-544_Seasonale.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021544s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021544Orig1s013ltr.pdf
11/05/2014 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/31/2017 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021544s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021544Orig1s009s010ltr.pdf
03/31/2017 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021544s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021544Orig1s009s010ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021544s013lbl.pdf
03/31/2017 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021544s009s010lbl.pdf
03/31/2017 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021544s009s010lbl.pdf
09/05/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21544_seasonale_lbl.pdf

SEASONALE

TABLET;ORAL; 0.03MG;0.15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ICLEVIA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 206850 AUROBINDO PHARMA LTD
INTROVALE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 079064 XIROMED
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 203871 AMNEAL PHARMS
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 203164 GLENMARK PHARMS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 091440 LUPIN LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 200490 MYLAN LABS LTD
QUASENSE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 077101 WATSON LABS
SEASONALE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription Yes AB 021544 TEVA BRANDED PHARM
SETLAKIN ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 090716 NOVAST LABS
SYLEVIA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL Prescription No AB 202988 SUN PHARM

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