Ipratropium Bromide and Albuterol Sulfate
Ipratropium Bromide and Albuterol Sulfate
Approved
Approval ID
001e3b1c-b7c1-44aa-b812-e78dbf4f3069
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2017
Manufacturers
FDA
Medical Supply Distribution, Llc.
DUNS: 080470358
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ipratropium Bromide and Albuterol Sulfate
PRODUCT DETAILS
NDC Product Code71152-201
Application NumberANDA076749
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 22, 2017
Generic NameIpratropium Bromide and Albuterol Sulfate
INGREDIENTS (5)
IPRATROPIUM BROMIDEActive
Quantity: 0.5 mg in 3 mL
Code: J697UZ2A9J
Classification: ACTIR
ALBUTEROL SULFATEActive
Quantity: 3 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT