Details for New Drug Application (NDA): 207511
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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 207511
Tradename: | OXYCODONE HYDROCHLORIDE |
Applicant: | Wes Pharma Inc |
Ingredient: | oxycodone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207511
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 207511
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 207511 | ANDA | MAJOR PHARMACEUTICALS | 0904-6678 | 0904-6678-40 | 1 BOTTLE, PLASTIC in 1 CARTON (0904-6678-40) / 500 mL in 1 BOTTLE, PLASTIC |
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 207511 | ANDA | MAJOR PHARMACEUTICALS | 0904-6828 | 0904-6828-92 | 5 TRAY in 1 CARTON (0904-6828-92) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-6828-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Nov 23, 2016 | TE: | AA | RLD: | No |
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