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Setid Eaecd9a1 E13e 49b1 8b3c 8e1ef016cacd Applno 50278 Form Capsule Oral Dosage 250mg - Drug Product Composition: Cefracycline tablets

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$ API Ref.Price (USD/KG) : 52Xls

USFDA APPLICATION NUMBER - 50278 / DOSAGE - CAPSULE;ORAL - 250MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRACYCLINE HYDROCHLORIDE(UNII: P6R62377KV)
(TETRACYCLINE - UNII:F8VB5M810T)
TETRACYCLINE HYDROCHLORIDE500mg | 250mg

Inactive Ingredients

Ingredient Name
Bryant Ranch Prepack
Alvogen Inc.
Chartwell RX, LLC
Harris Pharmaceutical, Inc
AvKARE, Inc.
Heritage Pharmaceuticals Inc.
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
REMEDYREPACK INC.
ALCOHOL(3K9958V90M)       
anhydrous lactose(3SY5LH9PMK)    
BENZYL ALCOHOL(LKG8494WBH)       
BUTYL ALCOHOL(8PJ61P6TS3)   
BUTYLPARABEN(3QPI1U3FV8)       
D&C YELLOW NO. 10(35SW5USQ3G) 
DIMETHICONE(92RU3N3Y1O)       
EDETATE CALCIUM DISODIUM(25IH6R4SGF)       
ETHYLENE GLYCOL MONOETHYL ETHER(IDK7C2HS09)       
FD&C blue no. 1(H3R47K3TBD)  
FD&C blue no. 2(L06K8R7DQK)   
FD&C red no. 40(WZB9127XOA)  
FD&C YELLOW NO. 6(H77VEI93A8) 
FERROSOFERRIC OXIDE(XM0M87F357)     
GELATIN(2G86QN327L)     
gelatin, unspecified(2G86QN327L)     
LACTOSE MONOHYDRATE(EWQ57Q8I5X)     
LACTOSE(J2B2A4N98G)       
LECITHIN, SOYBEAN(1DI56QDM62)       
LIGHT MINERAL OIL(N6K5787QVP)     
MAGNESIUM STEARATE(70097M6I30) 
METHYLPARABEN(A2I8C7HI9T)       
PROPYLENE GLYCOL(6DC9Q167V3)   
PROPYLPARABEN(Z8IX2SC1OH)       
SHELLAC(46N107B71O)   
SILICON DIOXIDE(ETJ7Z6XBU4)      
sodium lauryl sulfate(368GB5141J)     
SODIUM PROPIONATE(DK6Y9P42IN)       
STARCH, CORN(O8232NY3SJ)      
STEARIC ACID(4ELV7Z65AP)      
TITANIUM DIOXIDE(15FIX9V2JP) 
WATER(059QF0KO0R)