Details for New Drug Application (NDA): 022532
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NDA 022532 describes BEYAZ, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the BEYAZ profile page.
The generic ingredient in BEYAZ is drospirenone; ethinyl estradiol; levomefolate calcium. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.
The generic ingredient in BEYAZ is drospirenone; ethinyl estradiol; levomefolate calcium. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.
Summary for 022532
| Tradename: | BEYAZ |
| Applicant: | Bayer Hlthcare |
| Ingredient: | drospirenone; ethinyl estradiol; levomefolate calcium |
| Patents: | 2 |
Suppliers and Packaging for NDA: 022532
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532 | NDA AUTHORIZED GENERIC | Sandoz Inc | 0781-4075 | 0781-4075-15 | 3 BLISTER PACK in 1 CARTON (0781-4075-15) / 1 KIT in 1 BLISTER PACK (0781-4075-52) |
| BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-407 | 50419-407-00 | 90 BLISTER PACK in 1 PACKAGE (50419-407-00) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG | ||||
| Approval Date: | Sep 24, 2010 | TE: | AB | RLD: | Yes | ||||
| Patent: | 11,617,751 | Patent Expiration: | Jul 17, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | PREVENTION OF PREGNANCY | ||||||||
| Patent: | 11,617,751 | Patent Expiration: | Jul 17, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | RAISE FOLATE LEVELS IN WOMEN WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION FOR THE PURPOSE OF REDUCING THE RISK OF A NEURAL TUBE DEFECT IN A PREGNANCY | ||||||||
| Patent: | 11,617,751 | Patent Expiration: | Jul 17, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF MODERATE ACNE VULGARIS IN WOMEN AT LEAST 14 YEARS OF AGE IF THE PATIENT DESIRES AN ORAL CONTRACEPTIVE FOR BIRTH CONTROL | ||||||||
Expired US Patents for NDA 022532
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | RE37564 | ⤷ Subscribe |
| Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | 5,798,338 | ⤷ Subscribe |
| Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | RE38253 | ⤷ Subscribe |
| Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | RE37838 | ⤷ Subscribe |
| Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | 7,163,931 | ⤷ Subscribe |
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