Altabax
These highlights do not include all the information needed to use ALTABAX safely and effectively. See full prescribing information for ALTABAX. ALTABAX (retapamulin ointment), for topical use Initial U.S. Approval: 2007
Approved
Approval ID
7c91eee4-242b-4af2-a39b-7842a9d95143
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 5, 2023
Manufacturers
FDA
Almirall, LLC
DUNS: 605425912
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
retapamulin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16110-518
Application NumberNDA022055
Product Classification
M
Marketing Category
C73594
G
Generic Name
retapamulin
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 10, 2018
FDA Product Classification
INGREDIENTS (2)
RETAPAMULINActive
Quantity: 10 mg in 1 g
Code: 4MG6O8991R
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT