Details for New Drug Application (NDA): 204979
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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 204979
Tradename: | OXYCODONE HYDROCHLORIDE |
Applicant: | Ani Pharms |
Ingredient: | oxycodone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204979
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 204979
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 204979 | ANDA | ANI Pharmaceuticals, Inc. | 62559-151 | 62559-151-16 | 1 BOTTLE in 1 CARTON (62559-151-16) / 473 mL in 1 BOTTLE |
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 204979 | ANDA | ANI Pharmaceuticals, Inc. | 62559-151 | 62559-151-40 | 40 CUP, UNIT-DOSE in 1 CASE (62559-151-40) / 5 mL in 1 CUP, UNIT-DOSE (62559-151-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Jun 1, 2015 | TE: | AA | RLD: | No |
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