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Setid E7ea978d 00a1 4c60 97bc Bb1d37d776e9 Applno 21368 Form Tablet Oral Dosage 2 5mg - Drug Product Composition: Cialis

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$ API Ref.Price (USD/KG) : 481Xls

USFDA APPLICATION NUMBER - 21368 / DOSAGE - TABLET;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL(UNII: 742SXX0ICT)
(TADALAFIL - UNII:742SXX0ICT)
TADALAFIL20mg

Inactive Ingredients

Ingredient Name
Bryant Ranch Prepack
Cardinal Health
PD-Rx Pharmaceuticals, Inc.
Prasco Laboratories
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)   
Croscarmellose sodium(M28OL1HH48)
FERRIC OXIDE RED(1K09F3G675)  
Ferric Oxide Yellow(EX438O2MRT)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)   
Hydroxypropyl Cellulose (1600000 WAMW)(RFW2ET671P)  
HYDROXYPROPYL CELLULOSE(RFW2ET671P)   
Hydroxypropyl Cellulose, Unspecified(9XZ8H6N6OH) 
Hypromellose, Unspecified(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)   
Lactose monohydrate(EWQ57Q8I5X)
Magnesium stearate(70097M6I30)
Microcrystalline cellulose(OP1R32D61U)
SODIUM LAURYL SULFATE(368GB5141J)
Talc(7SEV7J4R1U)
Titanium dioxide(15FIX9V2JP)
Triacetin(XHX3C3X673)