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FDA Approval

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE

CompanyAmerican Health Packaging (DUNS: 929561009)

Effective Date

October 4, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Salbutamol(2.5 mg in 3 mL)

Ipratropium(0.5 mg in 3 mL)

Products (1)

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE

NDC Product Code

60687-405

Application Number

ANDA202496

Marketing Category

ANDA (C73584)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

October 4, 2022

Ingredients

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SalbutamolActive

Code: 021SEF3731Class: ACTIMQuantity: 2.5 mg in 3 mL

IpratropiumActive

Code: J697UZ2A9JClass: ACTIRQuantity: 0.5 mg in 3 mL

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