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Details for New Drug Application (NDA): 016854

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NDA 016854 describes NORLESTRIN FE 2.5/50, which is a drug marketed by Parke Davis and is included in one NDA. Additional details are available on the NORLESTRIN FE 2.5/50 profile page.

The generic ingredient in NORLESTRIN FE 2.5/50 is ethinyl estradiol; ferrous fumarate; norethindrone acetate. There are twenty-six drug master file entries for this compound. Additional details are available on the ethinyl estradiol; ferrous fumarate; norethindrone acetate profile page.

Summary for NDA: 016854

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-28Strength0.05MG;75MG;2.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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