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FDA Approval

good neighbor pharmacy anti diarrheal anti gas

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

FDA Approval Summary

Company
Amerisource Bergen
DUNS: 007914906
Effective Date
April 8, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Loperamide(2 mg in 1 1)
Dimethicone(125 mg in 1 1)

Products1

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

good neighbor pharmacy anti diarrheal anti gas

Product Details

NDC Product Code
46122-620
Application Number
ANDA209837
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 8, 2025
Code: 77TI35393CClass: ACTIBQuantity: 2 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
Code: 92RU3N3Y1OClass: ACTIBQuantity: 125 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
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