FDA Approval Activities for this Drug…

Dilaudid (hydromorphone HCl, USP) Liquid & Tablets, 1 mg/mL & 8 mg respectively, Abbott NDA 19-891/S-002 & 19-892/S-002 Hydromorphone Hydrochloride Injection, Faulding Pharmaceutical ANDA 76-444 4/25/03 Hydromorphone Hydrochloride Solution, 5 mg/5 mL, Roxane ANDA 74-653 7/29/98 8/5/98 Hydromorphone Hydrochloride Tablets USP, 8 mg, Roxane ANDA 74-597 HYDROMORPHONE HYDROCHLORIDE Injection 10MG/ML DILAUDID-HP Abbott 074598 HYDROMORPHONE HYDROCHLORIDE Injection 10MG/ML HYDROMORPHONE HCL Abbott 019034 HYDROMORPHONE HYDROCHLORIDE Injection 250MG/VIAL DILAUDID-HP Abbott 076444 HYDROMORPHONE HYDROCHLORIDE Injection 10MG/ML HYDROMORPHONE HCL Faulding 074317 HYDROMORPHONE HYDROCHLORIDE Injection 10MG/ML HYDROMORPHONE HCL STERIS 019891 HYDROMORPHONE HYDROCHLORIDE Solution; 5MG/5ML DILAUDID Abbott 074653 HYDROMORPHONE HYDROCHLORIDE Solution; 5MG/5ML HYDROMORPHONE HCL Roxane 019892 HYDROMORPHONE HYDROCHLORIDE Tablet; 8MG DILAUDID Abbott 074597 HYDROMORPHONE HYDROCHLORIDE Tablet; 8MG HYDROMORPHONE HCL Roxane | Hydromorphone Hydrochloride Tablets, Mallinckrodt, Approval

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