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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 021544

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NDA 021544 describes SEASONALE, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. Additional details are available on the SEASONALE profile page.

The generic ingredient in SEASONALE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for 021544

Tradename:	SEASONALE
Applicant:	Teva Branded Pharm
Ingredient:	ethinyl estradiol; levonorgestrel
Patents:	0

Suppliers and Packaging for NDA: 021544

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SEASONALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021544	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0555-9123	0555-9123-66	3 POUCH in 1 CARTON (0555-9123-66) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.03MG;0.15MG
Approval Date:	Sep 5, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021544

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	SEASONALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021544-001	Sep 5, 2003	5,898,032	⤷ Start Trial
Teva Branded Pharm	SEASONALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021544-001	Sep 5, 2003	RE39861	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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