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Setid 93902b00 6cbf 477d 9a3a E47b2c45ff96 Applno 21306 Form Film Extended Release Transdermal Dosage 7 5mcg Hr - Drug Product Composition: Buprenorphine

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$ API Ref.Price (USD/KG) : 21,065Xls

USFDA APPLICATION NUMBER - 21306 / DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 7.5MCG/HR

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
buprenorphine(UNII: 40D3SCR4GZ)
(buprenorphine - UNII:40D3SCR4GZ)
buprenorphine20ug in 1 | 10ug in 1 | 5ug in 1

Inactive Ingredients

Ingredient Name
A-S Medication Solutions LLC
Lake Erie Medical DBA Quality Care Products LLC
Purdue Pharma LP
Rhodes Pharmaceuticals L.P.
Teva Pharmaceuticals USA, Inc.
Apotex Corp.
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
ETHYL LEVULINATE(7BU24CSS2G)  
Levulinic Acid(RYX5QG61EI)     
OLEYL OLEATE(3X3L452Y85)
povidone(FZ989GH94E)     
POVIDONE, UNSPECIFIED(FZ989GH94E)