Sitavig
These highlights do not include all the information needed to use SITAVIG safely and effectively. See full prescribing information for SITAVIG. SITAVIG (acyclovir) buccal tablets Initial U.S. Approval: 1982
Approved
Approval ID
cd6e902d-5753-49ec-bec8-b27176ed978e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 11, 2020
Manufacturers
FDA
EPI Health, Inc
DUNS: 080638894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acyclovir
PRODUCT DETAILS
NDC Product Code71403-049
Application NumberNDA203791
Marketing CategoryC73594
Route of AdministrationBUCCAL
Effective DateDecember 1, 2019
Generic NameAcyclovir
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ACYCLOVIRActive
Quantity: 50 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT