Denavir
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1996
Approved
Approval ID
61229829-55a0-4d6f-a423-4b48a2b4d8e5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 26, 2018
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
penciclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-9720
Application NumberNDA020629
Product Classification
M
Marketing Category
C73594
G
Generic Name
penciclovir
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 1, 2018
FDA Product Classification
INGREDIENTS (7)
PENCICLOVIRActive
Quantity: 10 mg in 1 g
Code: 359HUE8FJC
Classification: ACTIB
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT