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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 214543

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NDA 214543 describes DROXIDOPA, which is a drug marketed by Adaptis, Alkem Labs Ltd, Annora, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Hikma, Jubilant Cadista, Lupin Pharms, Msn Pharms Inc, Sciegen Pharms Inc, Somerset Theraps Llc, Sun Pharm, Teva Pharms Usa Inc, Upsher Smith Labs, and Zydus Pharms, and is included in sixteen NDAs. It is available from fourteen suppliers. Additional details are available on the DROXIDOPA profile page.

The generic ingredient in DROXIDOPA is droxidopa. There are six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the droxidopa profile page.

Summary for 214543

Tradename:	DROXIDOPA
Applicant:	Somerset Theraps Llc
Ingredient:	droxidopa
Patents:	0

Medical Subject Heading (MeSH) Categories for 214543

Antiparkinson Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	May 5, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	May 5, 2021	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	May 5, 2021	TE:	AB	RLD:	No

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