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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 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. Nineteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
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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