Details for New Drug Application (NDA): 040834
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The generic ingredient in HYDROCODONE BITARTRATE AND ACETAMINOPHEN is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 040834
Tradename: | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
Applicant: | Pharm Assoc |
Ingredient: | acetaminophen; hydrocodone bitartrate |
Patents: | 0 |
Pharmacology for NDA: 040834
Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 040834
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | SOLUTION;ORAL | 040834 | ANDA | Genus Lifesciences Inc. | 64950-375 | 64950-375-16 | 473 mL in 1 BOTTLE (64950-375-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 325MG/15ML;10MG/15ML | ||||
Approval Date: | Apr 18, 2008 | TE: | RLD: | No |
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