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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 216994


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NDA 216994 describes ACETAMINOPHEN AND IBUPROFEN, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Glenmark Pharms Ltd, Granules, L Perrigo Co, Lnk Intl Inc, Marksans Pharma, Strides Pharma, and Taro, and is included in ten NDAs. It is available from forty-five suppliers. Additional details are available on the ACETAMINOPHEN AND IBUPROFEN profile page.

The generic ingredient in ACETAMINOPHEN AND IBUPROFEN is acetaminophen; ibuprofen. There are sixty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.
Summary for 216994
Tradename:ACETAMINOPHEN AND IBUPROFEN
Applicant:Marksans Pharma
Ingredient:acetaminophen; ibuprofen
Patents:0
Pharmacology for NDA: 216994
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 216994
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN AND IBUPROFEN acetaminophen; ibuprofen TABLET;ORAL 216994 ANDA TARGET CORPORATION 11673-924 11673-924-75 1 BOTTLE in 1 CARTON (11673-924-75) / 72 TABLET in 1 BOTTLE
ACETAMINOPHEN AND IBUPROFEN acetaminophen; ibuprofen TABLET;ORAL 216994 ANDA BETTER LIVING BRANDS, LLC 21130-716 21130-716-08 1 BOTTLE in 1 CARTON (21130-716-08) / 18 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength250MG;125MG
Approval Date:Jul 10, 2023TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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