Details for New Drug Application (NDA): 021840

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NDA 021840 describes SEASONIQUE, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SEASONIQUE profile page.

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

Summary for 021840

Tradename:	SEASONIQUE
Applicant:	Teva Branded Pharm
Ingredient:	ethinyl estradiol; levonorgestrel
Patents:	2

Suppliers and Packaging for NDA: 021840

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-3134	0093-3134-82	2 POUCH in 1 CARTON (0093-3134-82) / 1 BLISTER PACK in 1 POUCH (0093-3134-91) / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.03MG,0.01MG;0.15MG,N/A
Approval Date:	May 25, 2006	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jan 30, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION
Patent:	⤷ Sign Up	Patent Expiration:	Dec 5, 2028	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF PREGNANCY

Expired US Patents for NDA 021840

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006	⤷ Sign Up	⤷ Sign Up
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006	⤷ Sign Up	⤷ Sign Up
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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