Details for New Drug Application (NDA): 078591
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NDA 078591 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Barr, Hikma, Hospira, Hospira Inc, Rising, Watson Labs, Ascent Pharms Inc, Chartwell, Actavis Labs Fl Inc, Osmotica Pharm Us, Padagis Us, Aurolife Pharma Llc, Mpp Pharma, Nesher Pharms, and Specgx Llc, and is included in twenty-four NDAs. It is available from fourteen suppliers. Additional details are available on the HYDROMORPHONE HYDROCHLORIDE profile page.
The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Seventeen 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 |
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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