Details for New Drug Application (NDA): 205177
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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 205177
Tradename: | OXYCODONE HYDROCHLORIDE |
Applicant: | Ani Pharms |
Ingredient: | oxycodone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 205177
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 205177
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | CAPSULE;ORAL | 205177 | ANDA | ANI Pharmaceuticals, Inc. | 62559-167 | 62559-167-01 | 100 CAPSULE in 1 BOTTLE (62559-167-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
Approval Date: | Mar 31, 2016 | TE: | AB | RLD: | No |
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