Details for New Drug Application (NDA): 090485
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The generic ingredient in TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
Summary for 090485
Tradename: | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
Applicant: | Amneal Pharms |
Ingredient: | acetaminophen; tramadol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090485
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 090485
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | acetaminophen; tramadol hydrochloride | TABLET;ORAL | 090485 | ANDA | AvPAK | 50268-774 | 50268-774-15 | 50 BLISTER PACK in 1 BOX (50268-774-15) / 1 TABLET in 1 BLISTER PACK (50268-774-11) |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | acetaminophen; tramadol hydrochloride | TABLET;ORAL | 090485 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-617 | 53746-617-01 | 100 TABLET in 1 BOTTLE (53746-617-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;37.5MG | ||||
Approval Date: | Dec 9, 2009 | TE: | AB | RLD: | No |
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