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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 216592


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NDA 216592 describes ACETAMINOPHEN AND IBUPROFEN, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Glenmark Pharms Ltd, Granules, L Perrigo Co, and Marksans Pharma, and is included in seven NDAs. It is available from thirty-four 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.
Summary for 216592
Tradename:ACETAMINOPHEN AND IBUPROFEN
Applicant:Granules
Ingredient:acetaminophen; ibuprofen
Patents:0
Pharmacology for NDA: 216592
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 216592
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN AND IBUPROFEN acetaminophen; ibuprofen TABLET;ORAL 216592 ANDA WALGREENS 0363-9131 0363-9131-16 216 TABLET in 1 BOTTLE (0363-9131-16)
ACETAMINOPHEN AND IBUPROFEN acetaminophen; ibuprofen TABLET;ORAL 216592 ANDA WALGREENS 0363-9131 0363-9131-44 144 TABLET in 1 BOTTLE (0363-9131-44)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength250MG;125MG
Approval Date:Jul 13, 2023TE:RLD:No

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