Last Updated: November 9, 2026

Details for New Drug Application (NDA): 212835

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NDA 212835 describes DROXIDOPA, which is a drug marketed by Alkem Labs Ltd, Annora, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Hikma, Jubilant Cadista, Lupin Pharms, Msn Pharms Inc, Pharmazone, Sciegen Pharms, 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 thirteen suppliers. Additional details are available on the DROXIDOPA profile page.

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

Summary for 212835

Tradename:	DROXIDOPA
Applicant:	Hikma
Ingredient:	droxidopa
Patents:	0

Medical Subject Heading (MeSH) Categories for 212835

Antiparkinson Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Feb 18, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Feb 18, 2021	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Feb 18, 2021	TE:		RLD:	No

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