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Setid 913b6cfe 1fb0 44a8 817a 26374bbce995 Applno 22328 Form Tablet Sublingual Dosage 1 75mg - Drug Product Composition: Zolpimist

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$ API Ref.Price (USD/KG) : 621Xls

USFDA APPLICATION NUMBER - 22328 / DOSAGE - TABLET;SUBLINGUAL - 1.75MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
zolpidem tartrate(UNII: WY6W63843K)
(zolpidem - UNII:7K383OQI23)
zolpidem tartrate3.5mg | 1.75mg

Inactive Ingredients

Ingredient Name
Lupin Pharmaceuticals,Inc.
Novel Laboratories, Inc.
Purdue Pharma LP
ASPARTAME(Z0H242BBR1) 
croscarmellose sodium(M28OL1HH48)  
CROSPOVIDONE(2S7830E561)  
crospovidone(68401960MK)  
CROSPOVIDONE, UNSPECIFIED(2S7830E561)  
ferric oxide yellow(EX438O2MRT)  
MAGNESIUM STEARATE(70097M6I30) 
MANNITOL(3OWL53L36A)
POLYVINYL ACETATE PHTHALATE(58QVG85GW3) 
POVIDONE(FZ989GH94E) 
SILICON DIOXIDE(ETJ7Z6XBU4)
sodium bicarbonate (8MDF5V39QO)  
SODIUM BICARBONATE(8MDF5V39QO) 
sodium carbonate(45P3261C7T)
sodium stearyl fumarate(7CV7WJK4UI)  
sorbitol(506T60A25R)  
sucralose(96K6UQ3ZD4)