You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205120

✉ Email this page to a colleague

« Back to Dashboard

NDA 205120 describes BUTALBITAL AND ACETAMINOPHEN, which is a drug marketed by Dr Reddys Labs Sa, Granules, Alvogen, Anda Repository, Halsey, Lgm Pharma, Ne Rx Pharma, Pharmobedient, Quagen, Senores Pharms, and Watson Labs, and is included in thirteen NDAs. It is available from seven suppliers. Additional details are available on the BUTALBITAL AND ACETAMINOPHEN profile page.

The generic ingredient in BUTALBITAL AND ACETAMINOPHEN is acetaminophen; butalbital. There are sixty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.

Summary for 205120

Tradename:	BUTALBITAL AND ACETAMINOPHEN
Applicant:	Alvogen
Ingredient:	acetaminophen; butalbital
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	325MG;50MG
Approval Date:	Oct 30, 2015	TE:		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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.