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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 | Hydromorphone Hydrochloride Tablets, Amide Pharma, Approval | Hydromorphone Hydrochloride Tablets, KV Pharma, Approval | Dilaudid HP (hydromorphone hydrochloride) Injection, Abbott Labs, Labeling Revision | Dilaudid (hydromorphone hydrochloride) Tablets, Abbott Labs, Labeling Revision | Dilaudid (hydromorphone) Syrup, Abbott Labs, Labeling Revision | Hydromorphone Hydrochloride Tablets, Tyco Healthcare, Approval | DILAUDID (hydromorphone HCL) Tablets, Abbott Labs, Control Supplement | Hydromorphone Hydrochloride Injection, Hospira, Inc., Approval | Dilaudid-HP (hydromorphone hydrochloride) Injection, Purdue Pharma L.P., New Dosage Regimen | Hydromorphone Hydrochloride Tablets, Lannett Holdings, Inc., Approval | Exalgo (hydromorphone hrdrochloride) Extended-Release Tablets, ALZA Corporation, Approval | Hydromorphone Hydrochloride Injection, Akorn, Inc., Approval | Hydromorphone Hydrochloride Injection, Hospira, Inc., Tentative Approval | Dilaudid (hydromorphone hydrochloride) Injection, Purdue Pharma, LP, Labeling Revision | Dilaudid-HP (hydromorphone hydrochloride) Injection, Purdue Pharma, LP, Labeling Revision | Hydromorphone Hydrochloride Injection, Hospira, Inc., Approval
  
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