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Last Updated: April 18, 2024

Acetaminophen; butalbital; caffeine; codeine phosphate - Generic Drug Details


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What are the generic drug sources for acetaminophen; butalbital; caffeine; codeine phosphate and what is the scope of freedom to operate?

Acetaminophen; butalbital; caffeine; codeine phosphate is the generic ingredient in three branded drugs marketed by Able, Hikma, Hikma Intl Pharms, Lgm Pharma, Nostrum Labs Inc, Strides Pharma, Actavis Labs Ut Inc, and Valeant, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for acetaminophen; butalbital; caffeine; codeine phosphate
Pharmacology for acetaminophen; butalbital; caffeine; codeine phosphate

US Patents and Regulatory Information for acetaminophen; butalbital; caffeine; codeine phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Strides Pharma BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 204649-001 Jul 8, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Able BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 076528-001 Aug 21, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nostrum Labs Inc BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 075929-001 Apr 22, 2002 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Labs Ut Inc FIORICET W/ CODEINE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 020232-001 Jul 30, 1992 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Valeant PHRENILIN WITH CAFFEINE AND CODEINE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 074911-001 Aug 22, 2001 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lgm Pharma BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 076560-001 Jun 10, 2004 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 215138-002 Jan 26, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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