Details for New Drug Application (NDA): 212428
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The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty-one drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 212428
Tradename: | OXCARBAZEPINE |
Applicant: | Chartwell Rx |
Ingredient: | oxcarbazepine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212428
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 212428
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXCARBAZEPINE | oxcarbazepine | SUSPENSION;ORAL | 212428 | ANDA | Chartwell RX, LLC | 62135-841 | 62135-841-24 | 20 CUP, UNIT-DOSE in 1 CARTON (62135-841-24) / 5 mL in 1 CUP, UNIT-DOSE (62135-841-45) |
OXCARBAZEPINE | oxcarbazepine | SUSPENSION;ORAL | 212428 | ANDA | Chartwell RX, LLC | 62135-841 | 62135-841-54 | 250 mL in 1 BOTTLE (62135-841-54) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 300MG/5ML | ||||
Approval Date: | Jun 21, 2021 | TE: | AB | RLD: | No |
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