Application Information

This drug has been submitted to the FDA under the reference 084901/001.

Names and composition

"PROMETHACON" is the commercial name of a drug composed of PROMETHAZINE HYDROCHLORIDE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
084901/001 PROMETHACON PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 25MG
084902/001 PROMETHACON PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 50MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
007935/002 PHENERGAN PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
007935/003 PHENERGAN PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
007935/004 PHENERGAN PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
008381/003 PROMETHAZINE HYDROCHLORIDE PLAIN PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 25MG per 5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
008381/004 PROMETHAZINE HYDROCHLORIDE PLAIN PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 6.25MG per 5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
008857/002 PHENERGAN PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML
008857/003 PHENERGAN PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 50MG per ML
010926/001 PHENERGAN PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
010926/002 PHENERGAN PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
011689/001 PHENERGAN PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
040026/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 6.25MG per 5ML
040372/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML
040372/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 50MG per ML
040428/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 25MG
040428/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 12.5MG
040449/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 50MG
040454/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
040454/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 50MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
040471/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML
040479/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 12.5MG
040479/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 25MG
040500/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 12.5MG
040500/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 25MG
040504/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 12.5MG
040504/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 25MG
040515/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML
040524/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML
040524/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 50MG per ML
040558/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
040558/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
040558/003 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
040593/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML
040593/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 50MG per ML
040596/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
040596/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
040596/003 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
040603/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 12.5MG
040603/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 25MG
040622/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
040622/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
040622/003 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
040643/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 6.25MG per 5ML
040673/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
040673/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
040673/003 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
040712/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
040712/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
040712/003 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
040713/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
040718/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 6.25MG per 5ML
040724/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
040724/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
040737/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML
040737/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 50MG per ML
040785/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML
040785/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 50MG per ML
040791/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
040863/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
040863/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
040863/003 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
040882/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 6.25MG per 5ML
040891/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 6.25MG per 5ML
080629/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 50MG per ML
080949/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
080949/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
080949/003 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
083176/001 REMSED PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
083176/002 REMSED PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
083204/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
083214/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
083312/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML
083312/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 50MG per ML
083401/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
083403/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
083426/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
083532/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML
083532/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 50MG per ML
083603/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
083604/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
083613/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
083658/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
083711/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
083712/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
083838/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 50MG per ML
083955/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 50MG per ML
083955/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML
083997/001 ZIPAN-25 PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML
083997/002 ZIPAN-50 PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 50MG per ML
084027/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
084080/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
084160/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
084166/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
084176/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
084176/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
084176/003 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
084214/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
084222/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 50MG per ML
084223/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML
084233/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
084539/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
084554/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
084555/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
084557/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
084591/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML
084772/001 PROMETH FORTIS PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 25MG per 5ML
084901/001 PROMETHACON PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 25MG
084902/001 PROMETHACON PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 50MG
085146/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
085146/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
085385/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 25MG per 5ML
085388/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 6.25MG per 5ML
085664/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
085684/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
085953/001 PROMETH PLAIN PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 6.25MG per 5ML
085986/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
086395/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 6.25MG per 5ML
087165/001 PROMETHEGAN PROMETHAZINE HYDROCHLORIDE SUPPOSITORY/RECTAL 50MG
087518/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 6.25MG per 5ML
087953/001 PROMETHAZINE PLAIN PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 6.25MG per 5ML
087996/001 MYMETHAZINE FORTIS PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 25MG per 5ML
089013/001 PROMETHAZINE PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 6.25MG per 5ML
089109/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
089463/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 25MG per ML
089477/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTABLE/INJECTION 50MG per ML
091054/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
091054/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
091054/003 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
091179/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
091179/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
091179/003 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG
091675/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 6.25MG per 5ML
209177/001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 12.5MG
209177/002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 25MG
209177/003 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET/ORAL 50MG

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