FOR THE HEALTHCARE PROVIDER: When Perforomist® Inhalation Solution is dispensed to the patient, write an expiration date in the "Use by" box on the carton or dispensing container. The date should not exceed either 3 months from date dispensed or the expiration date on the product, whichever comes first. After dispensing to the patient, store at 2°C to 25°C (36°F to 77°F) for up to 3 months.

FOR THE PATIENT: Use Perforomist® Inhalation Solution prior to the "Use by" date.

Rx Only

U.S. Pat. Nos. 6,667,344 and 6,814,953
Mylan Specialty L.P., Morgantown, WV 26505

Manufactured for:
Mylan Specialty L.P.
Morgantown, WV 26505

Manufactured by:
The Ritedose Corporation
Columbia, SC 29203
02-487-00
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INGREDIENTS AND APPEARANCE
PERFOROMIST 
formoterol fumarate dihydrate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49502-605
Route of Administration RESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FORMOTEROL FUMARATE (UNII: W34SHF8J2K) (FORMOTEROL - UNII:5ZZ84GCW8B) FORMOTEROL FUMARATE ANHYDROUS 20 ug  in 2 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49502-605-61 60 in 1 CARTON 10/01/2007 
1 NDC:49502-605-95 1 in 1 POUCH  
1  2 mL in 1 VIAL; Type 0: Not a Combination Product  
2 NDC:49502-605-30 30 in 1 CARTON 10/01/2007 
2  1 in 1 POUCH  
2  2 mL in 1 VIAL; Type 0: Not a Combination Product  
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022007 10/01/2007