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Details for New Drug Application (NDA): 078778

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NDA 078778 describes TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, which is a drug marketed by Watson Labs, Micro Labs Ltd India, Mylan, Zydus Pharms Usa Inc, Par Pharm, Atlas Pharms Llc, Apotex Inc, Sun Pharm Inds Inc, and Amneal Pharms, and is included in nine NDAs. It is available from thirty-three suppliers. Additional details are available on the TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN profile page.

The generic ingredient in TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN is acetaminophen; tramadol hydrochloride. There are sixty-five drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

Summary for NDA: 078778

Apotex Inc
acetaminophen; tramadol hydrochloride
Formulation / Manufacturing:see details

Pharmacology for NDA: 078778

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 078778

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
acetaminophen; tramadol hydrochloride
TABLET;ORAL 078778 ANDA A-S Medication Solutions 50090-2730 50090-2730-0 20 TABLET in 1 BOTTLE (50090-2730-0)
acetaminophen; tramadol hydrochloride
TABLET;ORAL 078778 ANDA Golden State Medical Supply, Inc. 60429-500 60429-500-01 100 TABLET in 1 BOTTLE (60429-500-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;37.5MG
Approval Date:Apr 7, 2014TE:ABRLD:No

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