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FDA Approval

CHOLESTYRAMINE LIGHT

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

FDA Approval Summary

Company
EPIC PHARMA, LLC
DUNS: 827915443
Effective Date
December 15, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cholestyramine(4 g in 5.7 g)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

EPIC PHARMA, LLC

827915443

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

EPIC PHARMA, LLC

EPIC PHARMA, LLC

EPIC PHARMA, LLC

827915443

Products1

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

CHOLESTYRAMINE LIGHT

Product Details

NDC Product Code
42806-269
Application Number
ANDA074558
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 15, 2021
Code: 4B33BGI082Class: ACTIBQuantity: 4 g in 5.7 g
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FRUCTOSEInactive
Code: 6YSS42VSEVClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26CClass: IACT
ORANGEInactive
Code: 5EVU04N5QUClass: IACT
PECTINInactive
Code: 89NA02M4RXClass: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
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