Details for New Drug Application (NDA): 216749
✉ Email this page to a colleague
The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty-one drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 216749
Tradename: | OXCARBAZEPINE |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | oxcarbazepine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216749
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 216749
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXCARBAZEPINE | oxcarbazepine | SUSPENSION;ORAL | 216749 | ANDA | Camber Pharmaceuticals, Inc. | 31722-687 | 31722-687-25 | 1 BOTTLE in 1 CARTON (31722-687-25) / 250 mL in 1 BOTTLE |
OXCARBAZEPINE | oxcarbazepine | SUSPENSION;ORAL | 216749 | ANDA | NorthStar RxLLC | 72603-252 | 72603-252-01 | 1 BOTTLE in 1 CARTON (72603-252-01) / 250 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 300MG/5ML | ||||
Approval Date: | Oct 20, 2023 | TE: | AB | RLD: | No |
Complete Access Available with Subscription