lördag 19 april 2014

Propoxyphene Drug Product Applications for Which FDA Proposes To Withdraw Approval

Application No.DrugApplicant or holder
ANDA 083544Kesso-Gesic (propoxyphene hydrochloride (HCl)) Capsules, 65 milligrams (mg)MK Laboratories Inc., 424 Grasmere Ave., Fairfield, CT 06430.
ANDA 084551Propoxyphene HCl Capsules, 65 mgWhiteworth Towne Paulsen Inc.
ANDA 084553Compound 65 (aspirin, caffeine, and propoxyphene HCl) Capsules, 389 mg/32.4 mg/65 mgAlra Labs, 3850 Clearview Ct., Gurnee, IL 60031.

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