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FDA Approval

QUESTRAN

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
November 1, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cholestyramine(4 g in 5 g)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

QUESTRAN

Product Details

NDC Product Code
49884-937
Application Number
ANDA077203
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 17, 2018
Code: 4B33BGI082Class: ACTIBQuantity: 4 g in 5 g
ACACIAInactive
Code: 5C5403N26OClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT

QUESTRAN

Product Details

NDC Product Code
49884-936
Application Number
ANDA077204
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 17, 2018
Code: 4B33BGI082Class: ACTIBQuantity: 4 g in 9 g
ACACIAInactive
Code: 5C5403N26OClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
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