Details for New Drug Application (NDA): 209897
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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 209897
Tradename: | OXYCODONE HYDROCHLORIDE |
Applicant: | Wes Pharma Inc |
Ingredient: | oxycodone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209897
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 209897
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 209897 | ANDA | ALTANTIC BIOLOGICALS CORP | 17856-0023 | 17856-0023-1 | 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0023-1) / .5 mL in 1 SYRINGE |
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 209897 | ANDA | ALTANTIC BIOLOGICALS CORP | 17856-0023 | 17856-0023-2 | 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0023-2) / .125 mL in 1 SYRINGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 100MG/5ML | ||||
Approval Date: | Sep 6, 2017 | TE: | AA | RLD: | No |
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