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ESTROSTEP FE (nda020130)- (0.02MG,0.03MG,0.035MG;1MG,1MG,1MG)

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL
0.02MG,0.03MG,0.035MG;1MG,1MG,1MG
Yes No
2008-Apr-23 Expired
None None
None No
ESTROSTEP Fe is indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. ESTROSTEP Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications.
4 0 3
Total Other Developers None
Drugs with Suitability No
0.02MG,0.03MG,0.035MG;1MG,1MG,1MG ** ** - 3 -
NDA Sales Available Total Generic Sales Available
No 3
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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