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Setid 3684398d 4df6 4e42 Bfa0 1cc78b59f7ee Applno 11757 Form Injectable Injection Dosage 40mg Ml - Drug Product Composition: Methylprednisolone Acetate

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$ API Ref.Price (USD/KG) : 1,388Xls

USFDA APPLICATION NUMBER - 11757 / DOSAGE - INJECTABLE;INJECTION - 40MG/ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE ACETATE(UNII: 43502P7F0P)
(METHYLPREDNISOLONE - UNII:X4W7ZR7023)
METHYLPREDNISOLONE ACETATE40mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
Northstar RxLLC
Pharmacia & Upjohn Company LLC
Pharmacia and Upjohn Company LLC
REMEDYREPACK INC.
Sandoz Inc
Teva Parenteral Medicines, Inc.
RX PHARMA-PACK, INC.
Cardinal Health
Terrain Pharmaceuticals
REMEDYREPACK INC.
BENZYL ALCOHOL(LKG8494WBH)    
CITRIC ACID MONOHYDRATE(2968PHW8QP)          
HYDROCHLORIC ACID(QTT17582CB) 
MIRIPIRIUM CHLORIDE(3D6CWI0P23)        
NONOXYNOL-9(48Q180SH9T)          
POLYETHYLENE GLYCOL 3350(G2M7P15E5P) 
POLYSORBATE 80(6OZP39ZG8H)    
SODIUM CHLORIDE(451W47IQ8X) 
sodium hydroxide(55X04QC32I) 
SODIUM PHOSPHATE, DIBASIC(GR686LBA74)        
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(22ADO53M6F)       
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(GR686LBA74)        
SODIUM PHOSPHATE, MONOBASIC(3980JIH2SW)         
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(593YOG76RN)       
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM(3980JIH2SW)        
WATER(059QF0KO0R)