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Imprese · 25/10/20191 min di lettura
Allergan Pharmaceuticals International, LTD; Withdrawal of Approval of a New Drug Application for LO MINASTRIN FE
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Riepilogo
The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for LO MINASTRIN FE (ethinyl estradiol tablets, 0.01 milligrams (mg); ethinyl estradiol and norethindrone acetate tablets, 0.01 mg/1mg; and ferrous fumarate tablets, 75 mg), held by Allergan Pharmaceuticals International, LTD, c/o Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ 07940 (Allergan). Allergan notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →