Application Information

This drug has been submitted to the FDA under the reference 021945/001.

Names and composition

"MAKENA" is the commercial name of a drug composed of HYDROXYPROGESTERONE CAPROATE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
021945/001 MAKENA HYDROXYPROGESTERONE CAPROATE SOLUTION/INTRAMUSCULAR 1250MG per 5ML (250MG per ML)

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
010347/002 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
010347/004 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
016911/001 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
016911/002 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
017439/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML
017439/002 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML
018004/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML
021945/001 MAKENA HYDROXYPROGESTERONE CAPROATE SOLUTION/INTRAMUSCULAR 1250MG per 5ML (250MG per ML)
021945/002 MAKENA PRESERVATIVE FREE HYDROXYPROGESTERONE CAPROATE SOLUTION/INTRAMUSCULAR 250MG per ML (250MG per ML)
021945/003 MAKENA PRESERVATIVE FREE HYDROXYPROGESTERONE CAPROATE SOLUTION/INTRAMUSCULAR 250MG per ML (250MG per ML)
089330/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE Injectable/ Injection 125MG per ML
089331/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE Injectable/ Injection 250MG per ML
200271/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML

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