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Setid 333c955b C9a5 40bd Ad7b 2db144aa5866 Applno 22309 Form Gel Transdermal Dosage 1 62 40 5mg 2 5gm Packet - Drug Product Composition: AndroGel

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$ API Ref.Price (USD/KG) : 605Xls

USFDA APPLICATION NUMBER - 22309 / DOSAGE - GEL;TRANSDERMAL - 1.62% (40.5MG/2.5GM PACKET)

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
testosterone(UNII: 3XMK78S47O)
(testosterone - UNII:3XMK78S47O)
testosterone16.2mg in 1

Inactive Ingredients

Ingredient Name
A-S Medication Solutions LLC
Zydus Pharmaceuticals USA Inc
alcohol(3K9958V90M)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(4Q93RCW27E) 
carbomer homopolymer type C(4Q93RCW27E) 
isopropyl myristate(0RE8K4LNJS)
sodium hydroxide(55X04QC32I)
water(059QF0KO0R)