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Ipratropium Bromide

Ipratropium Bromide Inhalation Solution 0.02%

Approved
Approval ID

7159cf05-da58-4eb9-9e6d-a7f24eec5f46

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 4, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

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

Ipratropium Bromide

PRODUCT DETAILS

NDC Product Code50090-0668
Application NumberANDA075693
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 19, 2022
Generic NameIpratropium Bromide

INGREDIENTS (4)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
IPRATROPIUM BROMIDEActive
Quantity: 0.5 mg in 2.5 mL
Code: J697UZ2A9J
Classification: ACTIR
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Ipratropium Bromide - FDA Drug Approval Details