Last Updated: November 8, 2026

Details for New Drug Application (NDA): 087083

« Back to Dashboard

NDA 087083 describes ACETAMINOPHEN AND CODEINE PHOSPHATE, which is a drug marketed by Teva, Actavis Mid Atlantic, Chartwell, Chartwell Molecular, Dava Pharms Inc, Pai Holdings, Pharmobedient, Strides Pharma, Able, Adaptis, Am Therap, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, Mutual Pharm, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Strides Pharma Intl, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, and Whiteworth Town Plsn, and is included in eighty-nine NDAs. It is available from twenty-four suppliers. Additional details are available on the ACETAMINOPHEN AND CODEINE PHOSPHATE profile page.

The generic ingredient in ACETAMINOPHEN AND CODEINE PHOSPHATE is acetaminophen; codeine phosphate. There is one drug master file entry for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

Summary for 087083

Tradename:	ACETAMINOPHEN AND CODEINE PHOSPHATE
Applicant:	Sun Pharm Inds Ltd
Ingredient:	acetaminophen; codeine phosphate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG;60MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AA	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.