Last Updated: September 24, 2026

Details for New Drug Application (NDA): 219556

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NDA 219556 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, MSN, 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, Umedica Labs Pvt, and Zydus, and is included in thirty-two NDAs. It is available from forty-three suppliers. Additional details are available on the OXCARBAZEPINE profile page.

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

Summary for 219556

Tradename:	OXCARBAZEPINE
Applicant:	Epic Pharma Llc
Ingredient:	oxcarbazepine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Mar 2, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Mar 2, 2026	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Mar 2, 2026	TE:	AB	RLD:	No

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