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Setid 254422f6 37e0 4dc1 Ad3b B2e20009a7b5 Applno 21457 Form Aerosol Metered Inhalation Dosage Eq 0 09mg Base Inh - Drug Product Composition: Proventil Repetabs, Solution, Syrup, and Tablets

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

USFDA APPLICATION NUMBER - 21457 / DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE(UNII: 021SEF3731)
(ALBUTEROL - UNII:QF8SVZ843E)
ALBUTEROL90ug

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
HF Acquisition Co LLC, DBA HealthFirst
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
Lupin Pharmaceuticals, Inc.
Merck Sharp & Dohme Corp.
NuCare Pharmaceuticals,Inc.
Par Pharmaceutical Inc.
Preferred Relabeled By: Preferred Pharmaceuticals Inc.
Proficient Rx LP
REMEDYREPACK INC.
RPK Pharmaceuticals, Inc.
Advanced Rx Pharmacy of Tennessee, LLC
Clinical Solutions Wholesale
Prasco Laboratories
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
Unit Dose Services
ALCOHOL(3K9958V90M)      
NORFLURANE(DH9E53K1Y8)
oleic acid(2UMI9U37CP)