Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Pfizer Inc
113480771
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Pharmacia & Upjohn Company LLC
Parke-Davis Div of Pfizer Inc
Pfizer Inc
618054084
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dilantin Infatabs
Product Details
NDC Product Code
0071-0007Application Number
ANDA084427Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 21, 2022SUCROSEInactive
Code: C151H8M554Class: IACT
PhenytoinActive
Code: 6158TKW0C5Class: ACTIBQuantity: 50 mg in 1 1
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT