Details for New Drug Application (NDA): 078591
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The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 078591
Tradename: | HYDROMORPHONE HYDROCHLORIDE |
Applicant: | Hospira Inc |
Ingredient: | hydromorphone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078591
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 078591
Suppliers and Packaging for NDA: 078591
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | INJECTABLE;INJECTION | 078591 | ANDA | Hospira, Inc. | 0409-2634 | 0409-2634-01 | 10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2634-10) |
HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | INJECTABLE;INJECTION | 078591 | ANDA | Hospira, Inc. | 0409-2634 | 0409-2634-05 | 10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-2634-25) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
Approval Date: | Jun 17, 2008 | TE: | AP | RLD: | No |
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