Details for New Drug Application (NDA): 215265

NDA 215265 describes DROXIDOPA, which is a drug marketed by Adaptis, Ajanta Pharma Ltd, Alkem Labs Ltd, Annora, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Hikma, 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 fifteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the droxidopa profile page.

Summary for 215265

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

Pharmacology for NDA: 215265

Physiological Effect

Increased Blood Pressure

Medical Subject Heading (MeSH) Categories for 215265

Antiparkinson Agents

Suppliers and Packaging for NDA: 215265

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DROXIDOPA	droxidopa	CAPSULE;ORAL	215265	ANDA	Slate Run Pharmaceuticals, LLC	70436-140	70436-140-06	90 CAPSULE in 1 BOTTLE (70436-140-06)
DROXIDOPA	droxidopa	CAPSULE;ORAL	215265	ANDA	Slate Run Pharmaceuticals, LLC	70436-141	70436-141-06	90 CAPSULE in 1 BOTTLE (70436-141-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Nov 1, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Nov 1, 2021	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Nov 1, 2021	TE:	AB	RLD:	No

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