Details for New Drug Application (NDA): 021676

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NDA 021676 describes YAZ, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the YAZ profile page.

The generic ingredient in YAZ is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.

Summary for 021676

Tradename:	YAZ
Applicant:	Bayer Hlthcare
Ingredient:	drospirenone; ethinyl estradiol
Patents:	3

Suppliers and Packaging for NDA: 021676

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA Inc	0093-5423	0093-5423-58	3 BLISTER PACK in 1 PACKAGE (0093-5423-58) > 1 KIT in 1 BLISTER PACK (0093-5423-28)
YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA Inc	0093-5423	0093-5423-62	3 BLISTER PACK in 1 PACKAGE (0093-5423-62) > 1 KIT in 1 BLISTER PACK (0093-5423-28)

Paragraph IV (Patent) Challenges for 021676

Tradename	Dosage	Ingredient	NDA	Submissiondate
YAZ	TABLET;ORAL	drospirenone; ethinyl estradiol	021676	2006-09-29

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	3MG;0.02MG
Approval Date:	Mar 16, 2006	TE:	AB	RLD:	Yes
Patent:	Start Trial	Patent Expiration:	Aug 31, 2020	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	Start Trial	Patent Expiration:	Dec 20, 2021	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	Start Trial	Patent Expiration:	Dec 20, 2021	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF PREGNANCY

Expired US Patents for NDA 021676

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	Start Trial	Start Trial
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	Start Trial	Start Trial
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	Start Trial	Start Trial
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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