Pamine
Pamine 2.5 mg/Pamine Forte 5 mg
Approved
Approval ID
2981e734-2a20-4b45-8521-8c13ff2b6578
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 19, 2012
Manufacturers
FDA
PharmaDerm a division of Fougera Pharmaceuticals Inc.
DUNS: 043838424
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
methscopolamine bromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10337-062
Application NumberNDA008848
Product Classification
M
Marketing Category
C73594
G
Generic Name
methscopolamine bromide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2012
FDA Product Classification
INGREDIENTS (4)
METHSCOPOLAMINE BROMIDEActive
Quantity: 5 mg in 1 1
Code: RTN51LK7WL
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
methscopolamine bromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10337-061
Application NumberNDA008848
Product Classification
M
Marketing Category
C73594
G
Generic Name
methscopolamine bromide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2012
FDA Product Classification
INGREDIENTS (4)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METHSCOPOLAMINE BROMIDEActive
Quantity: 2.5 mg in 1 1
Code: RTN51LK7WL
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT