Topiramate
- Product NDC
- 57237-137
- 11-digit product format
- 572370137
- Labeler code
- 57237
- Product ID
- 57237-137_550b5383-3f5e-49c8-a3a4-cb29502bb8d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Citron Pharma LLC
- Application
- ANDA078462
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record