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Details for New Drug Application (NDA): 021676
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The generic ingredient in YAZ is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Nineteen 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
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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