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Generated: October 17, 2018

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CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride and what is the scope of codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride freedom to operate?

Codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride is the generic ingredient in seven branded drugs marketed by Ani Pharms, Halsey, Vintage, Actavis Mid Atlantic, Hi-tech Pharma Co, Amneal Pharms, Cenci, and Wockhardt, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. Four suppliers are listed for this compound.

Summary for CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Pharmacology for CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

US Patents and Regulatory Information for CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vintage PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040660-001 Dec 7, 2006 AA RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Halsey PHERAZINE VC W/ CODEINE codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 088870-001 Mar 2, 1987 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cenci PROMETHAZINE VC W/ CODEINE codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 088816-001 Nov 22, 1985 DISCN No No ➤ 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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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Merck
Colorcon
Farmers Insurance
Queensland Health
Argus Health
AstraZeneca
Boehringer Ingelheim
Fuji

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