Details for New Drug Application (NDA): 202662
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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 202662
Tradename: | OXYCODONE HYDROCHLORIDE |
Applicant: | Epic Pharma Llc |
Ingredient: | oxycodone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 202662
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 202662
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | TABLET;ORAL | 202662 | ANDA | Epic Pharma, LLC | 42806-005 | 42806-005-01 | 100 TABLET in 1 BOTTLE (42806-005-01) |
OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | TABLET;ORAL | 202662 | ANDA | Epic Pharma, LLC | 42806-006 | 42806-006-01 | 100 TABLET in 1 BOTTLE (42806-006-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Sep 22, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 22, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Sep 22, 2015 | TE: | AB | RLD: | No |
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