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Setid 5a90911e Adb5 4331 8d1a F791fba549f8 Applno 20950 Form Solution Inhalation Dosage Eq 0 083 Base 0 017 - Drug Product Composition: Proventil Repetabs, Solution, Syrup, and Tablets

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$ API Ref.Price (USD/KG) : 168Xls

USFDA APPLICATION NUMBER - 20950 / DOSAGE - SOLUTION;INHALATION - EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE(UNII: 021SEF3731)
(ALBUTEROL - UNII:QF8SVZ843E)
ALBUTEROL SULFATE3mg in 3
IPRATROPIUM BROMIDE(UNII: J697UZ2A9J)
(IPRATROPIUM - UNII:GR88G0I6UL)
IPRATROPIUM BROMIDE0.5mg in 3

Inactive Ingredients