Details for New Drug Application (NDA): 206914
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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 206914
Tradename: | OXYCODONE HYDROCHLORIDE |
Applicant: | Pharm Assoc |
Ingredient: | oxycodone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206914
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 206914
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 206914 | ANDA | PAI Holdings, LLC | 0121-0827 | 0121-0827-04 | 118 mL in 1 BOTTLE (0121-0827-04) |
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 206914 | ANDA | PAI Holdings, LLC | 0121-0827 | 0121-0827-16 | 500 mL in 1 BOTTLE (0121-0827-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Feb 1, 2019 | TE: | AA | RLD: | No |
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