TOPIRAMATE
- Product NDC
- 43063-094
- 11-digit product format
- 430630094
- Labeler code
- 43063
- Product ID
- 43063-094_8d55b333-e779-2b49-e053-2995a90ae5ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA079153
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 25 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
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record