MedPath
FDA Approval

Demerol

December 25, 2023

HUMAN PRESCRIPTION DRUG LABEL

Meperidine(50 mg in 1 1)

Products (2)

Demerol

30698-335

NDA005010

NDA (C73594)

ORAL

January 24, 2024

Code: N8E7F7Q170Class: ACTIBQuantity: 50 mg in 1 1
CALCIUM SULFATEInactive
Code: WAT0DDB505Class: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92JClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

Demerol

30698-337

NDA005010

NDA (C73594)

ORAL

January 24, 2024

CALCIUM SULFATEInactive
Code: WAT0DDB505Class: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92JClass: IACT
Code: N8E7F7Q170Class: ACTIBQuantity: 100 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
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