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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 075231


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NDA 075231 describes BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, which is a drug marketed by Dr Reddys Labs Sa, Lgm Pharma, Stevens J, Strides Pharma, and Watson Labs, and is included in five NDAs. It is available from five suppliers. Additional details are available on the BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE profile page.

The generic ingredient in BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE is aspirin; butalbital; caffeine; codeine phosphate. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine; codeine phosphate profile page.
Suppliers and Packaging for NDA: 075231
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE aspirin; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 075231 ANDA Breckenridge Pharmaceutical, Inc. 51991-074 51991-074-01 100 CAPSULE in 1 BOTTLE, PLASTIC (51991-074-01)
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE aspirin; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 075231 ANDA Breckenridge Pharmaceutical, Inc. 51991-074 51991-074-05 500 CAPSULE in 1 BOTTLE, PLASTIC (51991-074-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength325MG;50MG;40MG;30MG
Approval Date:Nov 30, 2001TE:ABRLD:No

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