Details for New Drug Application (NDA): 202142
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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-six suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.
Summary for 202142
Tradename: | OXYCODONE AND ACETAMINOPHEN |
Applicant: | Mikart |
Ingredient: | acetaminophen; oxycodone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 202142
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 202142
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE AND ACETAMINOPHEN | acetaminophen; oxycodone hydrochloride | SOLUTION;ORAL | 202142 | ANDA | Forte Bio-Pharma LLC | 72245-648 | 72245-648-12 | 120 mL in 1 BOTTLE, PLASTIC (72245-648-12) |
OXYCODONE AND ACETAMINOPHEN | acetaminophen; oxycodone hydrochloride | SOLUTION;ORAL | 202142 | ANDA | Forte Bio-Pharma LLC | 72245-648 | 72245-648-50 | 500 mL in 1 BOTTLE, PLASTIC (72245-648-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 300MG/5ML;10MG/5ML | ||||
Approval Date: | Nov 27, 2018 | TE: | RLD: | No |
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