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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 204649


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NDA 204649 describes BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, which is a drug marketed by Able, Hikma, Hikma Intl Pharms, Lgm Pharma, Nostrum Labs Inc, and Strides Pharma, and is included in six NDAs. It is available from four suppliers. Additional details are available on the BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE profile page.

The generic ingredient in BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE is acetaminophen; butalbital; caffeine; codeine phosphate. There are sixty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine; codeine phosphate profile page.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength325MG;50MG;40MG;30MG
Approval Date:Jul 8, 2020TE:ABRLD:No

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