EPURIS- isotretinoin capsule 
Galephar Pharmaceutical Research Inc.

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Epuris 10 mg Box of 3 blister cards

Epuris Mexico 10 mg

Epuris 20 mg Box of 3 blister cards

Epuris Mexico 20 mg

EPURIS 
isotretinoin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66277-335
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN20 mg
Inactive Ingredients
Ingredient NameStrength
PROPYL GALLATE (UNII: 8D4SNN7V92)  
SOYBEAN OIL (UNII: 241ATL177A)  
PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
Product Characteristics
ColorredScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code G241;20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66277-335-303 in 1 BOX10/01/2023
1NDC:66277-335-1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only10/01/2023
EPURIS 
isotretinoin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66277-336
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN10 mg
Inactive Ingredients
Ingredient NameStrength
PROPYL GALLATE (UNII: 8D4SNN7V92)  
SOYBEAN OIL (UNII: 241ATL177A)  
PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
Product Characteristics
ColoryellowScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code G240;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66277-336-303 in 1 BOX10/01/2023
1NDC:66277-336-1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only10/01/2023
Labeler - Galephar Pharmaceutical Research Inc. (003551624)
Registrant - Galephar Pharmaceutical Research Inc. (968996160)
Establishment
NameAddressID/FEIBusiness Operations
Galephar Pharmaceutical Research Inc968996160analysis(66277-335, 66277-336) , manufacture(66277-335, 66277-336) , pack(66277-335, 66277-336)

Revised: 10/2023
Document Id: 06e5e2b3-3b63-a816-e063-6394a90aa1f6
Set id: 06c2459c-ff0f-6f53-e063-6394a90a518a
Version: 2
Effective Time: 20231004
 
Galephar Pharmaceutical Research Inc.