QUESTRAN
Questran Powder for Oral Suspension
Approved
Approval ID
362ddd91-a63f-4ec6-841a-75785dd208c8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2019
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cholestyramine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-937
Application NumberANDA077203
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cholestyramine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (8)
CHOLESTYRAMINEActive
Quantity: 4 g in 5 g
Code: 4B33BGI082
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
Cholestyramine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-936
Application NumberANDA077204
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cholestyramine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (8)
CHOLESTYRAMINEActive
Quantity: 4 g in 9 g
Code: 4B33BGI082
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT