Details for New Drug Application (NDA): 202214
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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. Thirty-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 202214
Tradename: | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
Applicant: | Tris Pharma Inc |
Ingredient: | acetaminophen; hydrocodone bitartrate |
Patents: | 0 |
Pharmacology for NDA: 202214
Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 202214
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 202214 | ANDA | Tris Pharma Inc | 27808-035 | 27808-035-01 | 100 TABLET in 1 BOTTLE, PLASTIC (27808-035-01) |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 202214 | ANDA | Tris Pharma Inc | 27808-035 | 27808-035-02 | 500 TABLET in 1 BOTTLE, PLASTIC (27808-035-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;5MG | ||||
Approval Date: | Mar 27, 2013 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;7.5MG | ||||
Approval Date: | Mar 27, 2013 | TE: | AA | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;10MG | ||||
Approval Date: | Mar 27, 2013 | TE: | AA | RLD: | No |
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