Questa traduzione è in preparazione. Nel frattempo mostriamo temporaneamente la versione originale in inglese.
Imprese · 08/12/20231 min di lettura
Bayer HealthCare Pharmaceuticals Inc., et al.; Withdrawal of Approval of CIPRO (Ciprofloxacin Hydrochloride) Oral Tablet, Equivalent to 100 Milligrams Base, and Five Generic Ciprofloxacin Hydrochloride, Oral Tablet, Equivalent to 100 Milligrams Base Drug Products
Traduzione automatica locale · Lingua originale della fonte
Riepilogo
The Food and Drug Administration (FDA or the Agency) is withdrawing the approval of CIPRO (ciprofloxacin hydrochloride (HCl)) oral tablet, equivalent to (EQ) 100 milligrams (mg) base under new drug application (NDA) 019537 and five generic ciprofloxacin HCl, oral tablet, EQ 100 mg base products which referenced it as their basis of submission. The holders of the applications requested withdrawal of the 100 mg strength products and waived their opportunity for a hearing.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →