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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021840
Company: TEVA BRANDED PHARM

Products on NDA 021840

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021840

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
04/29/2022	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021840s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021840Orig1s015ltr.pdf
01/27/2023	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021840s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021840Orig1s012,s013ltr.pdf
01/27/2023	SUPPL-12	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021840s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021840Orig1s012,s013ltr.pdf
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

Labels for NDA 021840

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021840s012s013lbl.pdf
01/27/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021840s012s013lbl.pdf
01/27/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021840s012s013lbl.pdf
04/29/2022	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021840s015lbl.pdf
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

Therapeutic Equivalents for NDA 021840

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 PHARMS LTD
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	DR REDDYS LABS SA
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

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