Details for New Drug Application (NDA): 203107
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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 203107
Tradename: | OXYCODONE HYDROCHLORIDE |
Applicant: | Dr Reddys Labs Sa |
Ingredient: | oxycodone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203107
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 203107
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | CAPSULE;ORAL | 203107 | ANDA | Mayne Pharma Commercial LLC | 68308-145 | 68308-145-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (68308-145-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
Approval Date: | Jul 26, 2012 | TE: | RLD: | No |
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