budesonide inhalation
These highlights do not include all the information needed to use BUDESONIDE INHALATION SUSPENSION safely and effectively. See full prescribing information for BUDESONIDE INHALATION SUSPENSION. BUDESONIDE inhalation suspension.Initial U.S. Approval: 2000
Approved
Approval ID
944cbb7c-b41d-4a6d-8a93-2e646365c982
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
budesonide inhalation
PRODUCT DETAILS
NDC Product Code68180-984
Application NumberANDA210897
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 14, 2023
Generic Namebudesonide inhalation
INGREDIENTS (7)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
BUDESONIDEActive
Quantity: 0.5 mg in 2 mL
Code: Q3OKS62Q6X
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT