Details for New Drug Application (NDA): 206456
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The generic ingredient in OXYCODONE HYDROCHLORIDE is ibuprofen; oxycodone hydrochloride. There are sixty-four drug master file entries for this compound. Additional details are available on the ibuprofen; oxycodone hydrochloride profile page.
Summary for 206456
Tradename: | OXYCODONE HYDROCHLORIDE |
Applicant: | Pharmobedient Cnsltg |
Ingredient: | oxycodone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206456
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 206456
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 206456 | ANDA | Pharmaceutical Associates, Inc. | 0121-4839 | 0121-4839-40 | 4 TRAY in 1 CASE (0121-4839-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4839-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Jun 16, 2015 | TE: | RLD: | No |
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