An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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.html

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	NAARI PTE
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	XIROMED
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

Top