Details for New Drug Application (NDA): 021098
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The generic ingredient in YASMIN is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
Summary for 021098
Tradename: | YASMIN |
Applicant: | Bayer Hlthcare |
Ingredient: | drospirenone; ethinyl estradiol |
Patents: | 0 |
Suppliers and Packaging for NDA: 021098
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
YASMIN | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 021098 | NDA AUTHORIZED GENERIC | TEVA PHARMACEUTICALS USA, INC. | 0555-9131 | 0555-9131-67 | 3 BLISTER PACK in 1 PACKAGE (0555-9131-67) / 1 KIT in 1 BLISTER PACK (0555-9131-79) |
YASMIN | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 021098 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-402 | 50419-402-03 | 3 BLISTER PACK in 1 PACKAGE (50419-402-03) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 3MG;0.03MG | ||||
Approval Date: | May 11, 2001 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021098
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | YASMIN | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 021098-001 | May 11, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | YASMIN | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 021098-001 | May 11, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | YASMIN | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 021098-001 | May 11, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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