Details for New Drug Application (NDA): 200403
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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 200403
Tradename: | HYDROMORPHONE HYDROCHLORIDE |
Applicant: | Hospira Inc |
Ingredient: | hydromorphone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 200403
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 200403
Suppliers and Packaging for NDA: 200403
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | INJECTABLE;INJECTION | 200403 | NDA | Hospira, Inc. | 0409-1283 | 0409-1283-37 | 10 SYRINGE in 1 CELLO PACK (0409-1283-37) / 1 mL in 1 SYRINGE (0409-1283-17) |
HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | INJECTABLE;INJECTION | 200403 | NDA | Hospira, Inc. | 0409-1283 | 0409-1283-05 | 10 SYRINGE in 1 CARTON (0409-1283-05) / .5 mL in 1 SYRINGE (0409-1283-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
Approval Date: | Dec 1, 2011 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
Approval Date: | Dec 1, 2011 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 4MG/ML | ||||
Approval Date: | Dec 1, 2011 | TE: | RLD: | No |
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