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Setid F5525acb A982 45e8 8265 A7d7a7974141 Applno 21778 Form Suspension Oral Dosage 125mg Ml - Drug Product Composition: Megestrol acetole [Progestins]

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$ API Ref.Price (USD/KG) : 10,356Xls

USFDA APPLICATION NUMBER - 21778 / DOSAGE - SUSPENSION;ORAL - 125MG/ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEGESTROL ACETATE(UNII: TJ2M0FR8ES)
(MEGESTROL - UNII:EA6LD1M70M)
MEGESTROL ACETATE125mg in 1

Inactive Ingredients

Ingredient Name
AvKARE, Inc.
Breckenridge Pharmaceutical, Inc.
Physicians Total Care, Inc.
Proficient Rx LP
TWi Pharmaceuticals, Inc.
Atlantic Biologicals Corps
Bryant Ranch Prepack
Endo Pharmaceuticals Inc.
Par Pharmaceutical, Inc
Par Pharmaceutical, Inc.
ALCOHOL(3K9958V90M)     
ANHYDROUS CITRIC ACID(XF417D3PSL)         
ANHYDROUS TRISODIUM CITRATE(RS7A450LGA)         
CITRIC ACID MONOHYDRATE(2968PHW8QP)    
DOCUSATE SODIUM(F05Q2T2JA0)   
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)     
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)        
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)         
HYPROMELLOSES(3NXW29V3WO)        
LEMON(24RS0A988O)     
LIME (CITRUS)(8CZS546954)     
SODIUM BENZOATE(OJ245FE5EU)
SODIUM CITRATE(1Q73Q2JULR)         
SODIUM LAURYL SULFATE(368GB5141J)       
SUCROSE(C151H8M554)
TRISODIUM CITRATE DIHYDRATE(B22547B95K)  
WATER(059QF0KO0R)