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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 four suppliers. There are six 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 ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.

Summary for NDA: 021676

Tradename:
YAZ
Applicant:
Bayer Hlthcare
Ingredient:
drospirenone; ethinyl estradiol
Patents:6
Formulation / Manufacturing:see details

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 0093-5423-62 3 BLISTER PACK in 1 PACKAGE (0093-5423-62) > 1 KIT in 1 BLISTER PACK (0093-5423-28)
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL 021676 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-405 50419-405-03 3 BLISTER PACK in 1 PACKAGE (50419-405-03) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG;0.02MG
Approval Date:Mar 16, 2006TE:ABRLD:Yes
Patent:5,798,338Patent Expiration:Jul 10, 2015Product Flag?YSubstance Flag?Delist Request?
Patent:6,787,531Patent Expiration:Aug 31, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:6,933,395Patent Expiration:Aug 11, 2017Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021676

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 20065,569,652► subscribe
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006RE38253► subscribe
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006RE37838► subscribe
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