Details for New Drug Application (NDA): 040608
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The generic ingredient in OXYCODONE AND ACETAMINOPHEN is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.
Summary for 040608
Tradename: | OXYCODONE AND ACETAMINOPHEN |
Applicant: | Mikart |
Ingredient: | acetaminophen; oxycodone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 040608
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 040608
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE AND ACETAMINOPHEN | acetaminophen; oxycodone hydrochloride | TABLET;ORAL | 040608 | ANDA | Forte Bio-Pharma LLC | 72245-193 | 72245-193-03 | 30 TABLET in 1 BOTTLE, PLASTIC (72245-193-03) |
OXYCODONE AND ACETAMINOPHEN | acetaminophen; oxycodone hydrochloride | TABLET;ORAL | 040608 | ANDA | Forte Bio-Pharma LLC | 72245-193 | 72245-193-10 | 100 TABLET in 1 BOTTLE, PLASTIC (72245-193-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG;2.5MG | ||||
Approval Date: | Dec 30, 2005 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG;5MG | ||||
Approval Date: | Dec 30, 2005 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG;7.5MG | ||||
Approval Date: | Dec 30, 2005 | TE: | RLD: | No |
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