Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205637 08/05/2014  

BUNAVAIL  buprenorphine and naloxone film
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59385-014
Route of Administration BUCCAL DEA Schedule CIII    
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) BUPRENORPHINE 4.2 mg
NALOXONE HYDROCHLORIDE DIHYDRATE (UNII: 5Q187997EE) (NALOXONE - UNII:36B82AMQ7N) NALOXONE 0.7 mg
Product Characteristics
Color YELLOW Score no score
Shape RECTANGLE Size  
Flavor CITRUS Imprint Code BN4
Contains     
 
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59385-014-30 30 in 1 BOX    
1 NDC:59385-014-01 1 in 1 POUCH    
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205637 08/05/2014  
BUNAVAIL  buprenorphine and naloxone film
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59385-016
Route of Administration BUCCAL DEA Schedule CIII    
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) BUPRENORPHINE 6.3 mg
NALOXONE HYDROCHLORIDE DIHYDRATE (UNII: 5Q187997EE) (NALOXONE - UNII:36B82AMQ7N) NALOXONE 1 mg
Product Characteristics
Color YELLOW Score no score
Shape RECTANGLE Size  
Flavor CITRUS Imprint Code BN6
Contains     
 
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59385-016-30 30 in 1 BOX    
1 NDC:59385-016-01 1 in 1 POUCH    

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205637 08/05/2014