PHENYTOIN SODIUM

Product NDC
70518-0981
11-digit product format
705180981
Labeler code
70518
Product ID
70518-0981_8f7de1d0-b0a6-575f-e053-2995a90a2595
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYTOIN SODIUM
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040621
Marketing category
ANDA
Marketing start
2018-01-22
Marketing end
0000-00-00
Substance
PHENYTOIN SODIUM
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record