Ipratropium Bromide
Ipratropium Bromide Nasal Solution 0.06%(Nasal Spray)
Approved
Approval ID
09ab5bc2-645f-415d-ad76-246385690176
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-355
Application NumberANDA076103
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ipratropium Bromide
Product Specifications
Route of AdministrationNASAL
Effective DateApril 9, 2010
FDA Product Classification
INGREDIENTS (7)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
IPRATROPIUM BROMIDEActive
Quantity: 42 ug in 1 1
Code: J697UZ2A9J
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT