Details for New Drug Application (NDA): 040826
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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 040826
Tradename: | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
Applicant: | Sun Pharm Inds Ltd |
Ingredient: | acetaminophen; hydrocodone bitartrate |
Patents: | 0 |
Pharmacology for NDA: 040826
Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 040826
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040826 | ANDA | Sun Pharmaceutical Industries, Inc. | 63304-497 | 63304-497-01 | 100 TABLET in 1 BOTTLE (63304-497-01) |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040826 | ANDA | Sun Pharmaceutical Industries, Inc. | 63304-497 | 63304-497-03 | 10 TABLET in 1 BOTTLE (63304-497-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;10MG | ||||
Approval Date: | Aug 16, 2007 | TE: | RLD: | No |
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