Details for New Drug Application (NDA): 206245
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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 206245
Tradename: | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
Applicant: | Novel Labs Inc |
Ingredient: | acetaminophen; hydrocodone bitartrate |
Patents: | 0 |
Pharmacology for NDA: 206245
Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 206245
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 206245 | ANDA | Major Pharmaceuticals | 0904-6824 | 0904-6824-45 | 80 BLISTER PACK in 1 CARTON (0904-6824-45) / 1 TABLET in 1 BLISTER PACK |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 206245 | ANDA | Major Pharmaceuticals | 0904-6824 | 0904-6824-61 | 100 BLISTER PACK in 1 CARTON (0904-6824-61) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;5MG | ||||
Approval Date: | Dec 1, 2016 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;7.5MG | ||||
Approval Date: | Dec 1, 2016 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;10MG | ||||
Approval Date: | Dec 1, 2016 | TE: | RLD: | No |
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