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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 040885


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NDA 040885 describes BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, which is a drug marketed by Aurolife Pharma Llc, Dr Reddys Labs Sa, Gilbert Labs, Graham Dm, Granules, Hikma, Lannett Co Inc, Lgm Pharma, Mallinckrodt, Novast Labs, Nuvo Pharms Inc, Quagen, Rise Pharma, Taro, Xspire Pharma, Mikart, Abhai Llc, Able, Actavis Labs Ut Inc, Alvogen, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Sun Pharm Industries, Vintage Pharms, and Watson Labs, and is included in forty-four NDAs. It is available from thirty-three suppliers. Additional details are available on the BUTALBITAL, ACETAMINOPHEN AND CAFFEINE profile page.

The generic ingredient in BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is acetaminophen; butalbital; caffeine. There are sixty-six drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.
Summary for 040885
Pharmacology for NDA: 040885
Suppliers and Packaging for NDA: 040885
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 040885 ANDA Actavis Pharma, Inc. 0591-2640 0591-2640-01 100 CAPSULE in 1 BOTTLE (0591-2640-01)
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 040885 ANDA Actavis Pharma, Inc. 0591-2640 0591-2640-05 500 CAPSULE in 1 BOTTLE (0591-2640-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG;50MG;40MG
Approval Date:Nov 16, 2009TE:AARLD:No

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