Last Updated: May 3, 2026

Details for New Drug Application (NDA): 220281

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NDA 220281 describes OXCARBAZEPINE, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aucta, Biocon Pharma, Bionpharma, Chartwell Rx, Hetero Labs Ltd Iii, Hikma, Kanchan Hlthcare, Macleods Pharms Ltd, Pai Holdings, Rubicon Research, Steranco Hlthcare, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Apotex, Aurobindo Pharma Ltd, Riconpharma Llc, Ani Pharms, Annora Pharma, Breckenridge Pharm, Epic Pharma Llc, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, Taro, and Zydus, and is included in thirty NDAs. It is available from thirty-nine suppliers. Additional details are available on the OXCARBAZEPINE profile page.

The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty-one drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

Summary for 220281

Tradename:	OXCARBAZEPINE
Applicant:	Steranco Hlthcare
Ingredient:	oxcarbazepine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	300MG/5ML
Approval Date:	Mar 9, 2026	TE:	AB	RLD:	No

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