Details for New Drug Application (NDA): 040655
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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 040655
Tradename: | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
Applicant: | Strides Pharma |
Ingredient: | acetaminophen; hydrocodone bitartrate |
Patents: | 0 |
Pharmacology for NDA: 040655
Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 040655
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040655 | ANDA | Medsource Pharmaceticals | 45865-605 | 45865-605-15 | 15 TABLET in 1 BOTTLE, PLASTIC (45865-605-15) |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040655 | ANDA | Medsource Pharmaceticals | 45865-605 | 45865-605-20 | 20 TABLET in 1 BOTTLE, PLASTIC (45865-605-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;5MG | ||||
Approval Date: | Jan 19, 2006 | TE: | AA | RLD: | No |
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