IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE

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

Company

DUNS: 968062294

Effective Date

December 20, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ipratropium(0.5 mg in 3 mL)

Salbutamol(2.5 mg in 3 mL)

Products1

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

NDC Product Code

76204-600

Application Number

ANDA202496

Marketing Category

ANDA (C73584)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

December 20, 2023

Ingredients

Code: J697UZ2A9JClass: ACTIRQuantity: 0.5 mg in 3 mL

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