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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 213033


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NDA 213033 describes DROXIDOPA, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Annora, Aurobindo Pharma Ltd, Bionpharma, Bluepharma Industria, Chartwell Rx, Hikma, Lupin Pharms, Msn Pharms Inc, Sciegen Pharms Inc, Slate Run Pharma, 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 213033
Tradename:DROXIDOPA
Applicant:Bionpharma
Ingredient:droxidopa
Patents:0
Pharmacology for NDA: 213033
Physiological EffectIncreased Blood Pressure
Medical Subject Heading (MeSH) Categories for 213033
Suppliers and Packaging for NDA: 213033
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DROXIDOPA droxidopa CAPSULE;ORAL 213033 ANDA Bionpharma Inc. 69452-256 69452-256-19 90 CAPSULE in 1 BOTTLE, PLASTIC (69452-256-19)
DROXIDOPA droxidopa CAPSULE;ORAL 213033 ANDA Bionpharma Inc. 69452-257 69452-257-19 90 CAPSULE in 1 BOTTLE, PLASTIC (69452-257-19)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Apr 28, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Apr 28, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Apr 28, 2021TE:ABRLD:No

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