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Last Updated: November 22, 2024

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for codeine phosphate; promethazine hydrochloride and what is the scope of patent protection?

Codeine phosphate; promethazine hydrochloride is the generic ingredient in five branded drugs marketed by Ani Pharms, Halsey, Actavis Mid Atlantic, Amneal Pharms, Hikma, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Wockhardt Bio Ag, and Cenci, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
US Patents:0
Tradenames:5
Applicants:11
NDAs:12
Finished Product Suppliers / Packagers: 6
DailyMed Link:CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE at DailyMed
Pharmacology for CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Drug ClassOpioid Agonist
Phenothiazine
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cenci PROMETHAZINE W/ CODEINE codeine phosphate; promethazine hydrochloride SYRUP;ORAL 088814-001 Nov 22, 1985 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal Pharms PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE codeine phosphate; promethazine hydrochloride SYRUP;ORAL 200894-001 Apr 24, 2013 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Tris Pharma Inc PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE codeine phosphate; promethazine hydrochloride SYRUP;ORAL 200386-001 Jun 29, 2012 AA RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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