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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021544
Company: TEVA BRANDED PHARM

Products on NDA 021544

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021544

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
04/29/2022	SUPPL-17	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021544s017lbl.pdf
01/27/2023	SUPPL-15	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021544s014s015lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021544Orig1s014,s015ltr.pdf
01/27/2023	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021544s014s015lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021544Orig1s014,s015ltr.pdf
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

Labels for NDA 021544

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2023	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021544s014s015lbledt.pdf
01/27/2023	SUPPL-15	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021544s014s015lbledt.pdf
01/27/2023	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021544s014s015lbledt.pdf
04/29/2022	SUPPL-17	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021544s017lbl.pdf
04/29/2022	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021544s017lbl.pdf
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

Therapeutic Equivalents for NDA 021544

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

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