Details for New Drug Application (NDA): 022532
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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: | ⤷ Sign Up | Patent Expiration: | Jul 17, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | PREVENTION OF PREGNANCY | ||||||||
Patent: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | ⤷ Sign Up | ⤷ Sign Up |
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