Details for New Drug Application (NDA): 211748
✉ Email this page to a colleague
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 211748
Tradename: | OXYCODONE HYDROCHLORIDE |
Applicant: | Alkem Labs Ltd |
Ingredient: | oxycodone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211748
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 211748
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 211748 | ANDA | Ascend Laboratories, LLC | 67877-623 | 67877-623-19 | 15 mL in 1 BOTTLE, PLASTIC (67877-623-19) |
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 211748 | ANDA | Ascend Laboratories, LLC | 67877-623 | 67877-623-88 | 100 mL in 1 BOTTLE, PLASTIC (67877-623-88) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Feb 7, 2019 | TE: | AA | RLD: | No |
Complete Access Available with Subscription