MedPath
FDA Approval

Albuterol

February 20, 2023

HUMAN PRESCRIPTION DRUG LABEL

Salbutamol(4 mg in 1 1)

Manufacturing Establishments (1)

Amneal Pharmaceuticals Private Limited

Amneal Pharmaceuticals NY LLC

650762060

Products (2)

Albuterol

69238-1345

ANDA208804

ANDA (C73584)

ORAL

February 20, 2023

Code: 021SEF3731Class: ACTIMQuantity: 4 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Albuterol

69238-1344

ANDA208804

ANDA (C73584)

ORAL

February 20, 2023

Code: 021SEF3731Class: ACTIMQuantity: 2 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
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