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BEYAZ (nda022532)- (3MG,N/A;0.02MG,N/A;0.451MG,0.451MG)

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM BAYER HLTHCARE
3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Yes Yes
2030-Jul-17 Expired
None 2013-Sep-24
None No
Beyaz is an estrogen/progestin COC containing a folate, indicated for use by women to: • Prevent pregnancy. • Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception. • Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. • Raise folate levels in women who choose to use an oral contraceptive for contraception.
2 0 1
Total Other Developers 3
Drugs with Suitability No
3MG,N/A;0.02MG,N/A;0.451MG,0.451MG ** ** - - 1
NDA Sales Available Total Generic Sales Available
Yes 1
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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