Details for New Drug Application (NDA): 207418
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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 207418
Tradename: | OXYCODONE HYDROCHLORIDE |
Applicant: | Ascent Pharms Inc |
Ingredient: | oxycodone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 207418
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 207418
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | TABLET;ORAL | 207418 | ANDA | Camber Pharmaceuticals Inc | 31722-917 | 31722-917-01 | 100 TABLET in 1 BOTTLE (31722-917-01) |
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | TABLET;ORAL | 207418 | ANDA | Camber Pharmaceuticals Inc | 31722-917 | 31722-917-05 | 500 TABLET in 1 BOTTLE (31722-917-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Aug 7, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Aug 7, 2017 | TE: | AB | RLD: | No |
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