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Last Updated: March 28, 2024

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.
Summary for 022532
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:RXDosage:TABLET;ORALStrength3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Approval Date:Sep 24, 2010TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jul 17, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY
Patent:⤷  Try a TrialPatent Expiration:Jul 17, 2030Product Flag?YSubstance 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:⤷  Try a TrialPatent Expiration:Jul 17, 2030Product Flag?YSubstance 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

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