You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

Details for New Drug Application (NDA): 075964

✉ Email this page to a colleague

« Back to Dashboard

NDA 075964 describes TRAMADOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma Ltd, Endo Operations, Lupin Ltd, Mylan, Strides Pharma, Sun Pharm, Accord Hlthcare, Amneal Pharms, Apotex, Asta, Cspc Ouyi Pharm Co, Graviti Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Merro Pharm Usa, Mylan Pharms Inc, Northstar Hlthcare, Pliva, Rubicon, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Unichem, Watson Labs, Zydus Pharms Usa Inc, Alkem Labs Ltd, Aurobindo Pharma, Chartwell Rx, Micro Labs Ltd India, Nostrum Labs Inc, and Rising, and is included in forty-four NDAs. It is available from forty-three suppliers. Additional details are available on the TRAMADOL HYDROCHLORIDE profile page.

The generic ingredient in TRAMADOL HYDROCHLORIDE 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 075964

Tradename:	TRAMADOL HYDROCHLORIDE
Applicant:	Sun Pharm Inds Inc
Ingredient:	tramadol hydrochloride
Patents:	0

Pharmacology for NDA: 075964

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 075964

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 075964

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075964	ANDA	Major Pharmaceuticals	0904-7179	0904-7179-61	100 BLISTER PACK in 1 CARTON (0904-7179-61) / 1 TABLET in 1 BLISTER PACK
TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075964	ANDA	Medsource Pharmaceuticals	45865-115	45865-115-21	21 TABLET in 1 BOTTLE (45865-115-21)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jun 19, 2002	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.