Details for New Drug Application (NDA): 202159
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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 202159
Tradename: | HYDROMORPHONE HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | hydromorphone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202159
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 202159
Suppliers and Packaging for NDA: 202159
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | INJECTABLE;INJECTION | 202159 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6151 | 0641-6151-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6151-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6151-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
Approval Date: | Apr 27, 2018 | TE: | AP | RLD: | No |
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