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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 075794


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NDA 075794 describes ACETAMINOPHEN, ASPIRIN AND CAFFEINE, which is a drug marketed by Aurobindo Pharma Ltd, Granules, and Perrigo, and is included in three NDAs. It is available from thirty-nine suppliers. Additional details are available on the ACETAMINOPHEN, ASPIRIN AND CAFFEINE profile page.

The generic ingredient in ACETAMINOPHEN, ASPIRIN AND CAFFEINE is acetaminophen; aspirin; caffeine. There are sixty-six drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the acetaminophen; aspirin; caffeine profile page.
Summary for 075794
Suppliers and Packaging for NDA: 075794
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN, ASPIRIN AND CAFFEINE acetaminophen; aspirin; caffeine TABLET;ORAL 075794 ANDA L. Perrigo Company 0113-0374 0113-0374-62 1 BOTTLE in 1 CARTON (0113-0374-62) / 24 TABLET, FILM COATED in 1 BOTTLE
ACETAMINOPHEN, ASPIRIN AND CAFFEINE acetaminophen; aspirin; caffeine TABLET;ORAL 075794 ANDA L. Perrigo Company 0113-0374 0113-0374-78 1 BOTTLE in 1 CARTON (0113-0374-78) / 100 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength250MG;250MG;65MG
Approval Date:Nov 26, 2001TE:RLD:No

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