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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-five 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-six suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

Summary for NDA: 078778

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 A-S Medication Solutions 50090-2730 50090-2730-1 30 TABLET in 1 BOTTLE (50090-2730-1)

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.