Lamotrigine Extended Release
- Product NDC
- 70518-0489
- 11-digit product format
- 705180489
- Labeler code
- 70518
- Product ID
- 70518-0489_85478117-f45c-043b-e053-2991aa0af64a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lamotrigine extended release
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA201791
- Marketing category
- ANDA
- Marketing start
- 2017-05-08
- Marketing end
- 0000-00-00
- Substance
- LAMOTRIGINE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record