Details for New Drug Application (NDA): 074653
✉ Email this page to a colleague
The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 074653
Tradename: | HYDROMORPHONE HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | hydromorphone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074653
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 074653
Suppliers and Packaging for NDA: 074653
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | SOLUTION;ORAL | 074653 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0386 | 0054-0386-63 | 473 mL in 1 BOTTLE (0054-0386-63) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Jul 29, 1998 | TE: | AA | RLD: | No |
Complete Access Available with Subscription