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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 206597


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NDA 206597 describes HAILEY FE 1/20, which is a drug marketed by Glenmark Pharms Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the HAILEY FE 1/20 profile page.

The generic ingredient in HAILEY FE 1/20 is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 206597
Suppliers and Packaging for NDA: 206597
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HAILEY FE 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 206597 ANDA Glenmark Pharmaceuticals Inc., USA 68462-419 68462-419-29 3 BLISTER PACK in 1 CARTON (68462-419-29) / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.02MG;1MG
Approval Date:Nov 21, 2017TE:ABRLD:No

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