Details for New Drug Application (NDA): 204092
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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 204092
Tradename: | OXYCODONE HYDROCHLORIDE |
Applicant: | Dr Reddys Labs Sa |
Ingredient: | oxycodone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204092
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 204092
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 204092 | ANDA | Mayne Pharma Commercial LLC | 68308-020 | 68308-020-03 | 1 BOTTLE, PLASTIC in 1 CARTON (68308-020-03) / 30 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 100MG/5ML | ||||
Approval Date: | Jun 5, 2014 | TE: | RLD: | No |
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