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Last Updated: October 22, 2021

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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 Intl Pharms, Lgm Pharma, Nostrum Labs Inc, Strides Pharma, Actavis Labs Ut Inc, and Valeant, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-six drug master file entries for acetaminophen; butalbital; caffeine; codeine phosphate. 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
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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hikma Intl Pharms BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 075618-001 Mar 23, 2001 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Valeant PHRENILIN WITH CAFFEINE AND CODEINE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 074911-001 Aug 22, 2001 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Strides Pharma BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 204649-001 Jul 8, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lgm Pharma BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 076560-002 Jul 19, 2012 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Harvard Business School
Mallinckrodt
Baxter
Merck

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