Details for New Drug Application (NDA): 203638
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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 203638
Tradename: | OXYCODONE HYDROCHLORIDE |
Applicant: | Amneal Pharms |
Ingredient: | oxycodone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 203638
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 203638
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | TABLET;ORAL | 203638 | ANDA | Major Pharmaceuticals | 0904-6966 | 0904-6966-61 | 100 BLISTER PACK in 1 CARTON (0904-6966-61) / 1 TABLET in 1 BLISTER PACK |
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | TABLET;ORAL | 203638 | ANDA | Major Pharmaceuticals | 0904-7180 | 0904-7180-61 | 100 BLISTER PACK in 1 CARTON (0904-7180-61) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jun 3, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jun 3, 2014 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Jun 3, 2014 | TE: | AB | RLD: | No |
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