Details for New Drug Application (NDA): 213761
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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 213761
Tradename: | OXYCODONE HYDROCHLORIDE |
Applicant: | Quagen |
Ingredient: | oxycodone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213761
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 213761
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 213761 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-136 | 70752-136-10 | 1 BOTTLE, PLASTIC in 1 CARTON (70752-136-10) / 100 mL in 1 BOTTLE, PLASTIC |
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 213761 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-136 | 70752-136-14 | 1 BOTTLE, PLASTIC in 1 CARTON (70752-136-14) / 500 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Jun 2, 2021 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 100MG/5ML | ||||
Approval Date: | Jun 2, 2021 | TE: | AA | RLD: | No |
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