Details for New Drug Application (NDA): 204603
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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 204603
Tradename: | OXYCODONE HYDROCHLORIDE |
Applicant: | Novel Labs Inc |
Ingredient: | oxycodone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204603
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 204603
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 204603 | ANDA | Lupin Pharmaceuticals, Inc. | 43386-920 | 43386-920-60 | 1 BOTTLE in 1 CARTON (43386-920-60) / 30 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 100MG/5ML | ||||
Approval Date: | Apr 29, 2015 | TE: | RLD: | No |
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