Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com