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Aurobindo Receives FDA Approval for Oshih (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 mg/20 mcg

Published: December 06, 2023

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Oshih (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 mg/20 mcg. Aurobindo Pharma’s Oshih (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), are an AB-rated generic equivalent to the reference listed drug (RLD), Minastrin 24 Fe Tablets manufactured by Allergan Pharmaceuticals International Limited.

Oshih (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets) are indicated for:

  • Use by females of reproductive age to prevent pregnancy.