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Last Updated: August 9, 2020

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Details for New Drug Application (NDA): 207613

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NDA 207613 describes MIDODRINE HYDROCHLORIDE, which is a drug marketed by Apotex, Chartwell Rx, Impax Pharms, Mylan Pharms Inc, Par Pharm Inc, Rubicon, and Unique Pharm Labs, and is included in seven NDAs. It is available from fifteen suppliers. Additional details are available on the MIDODRINE HYDROCHLORIDE profile page.

The generic ingredient in MIDODRINE HYDROCHLORIDE is midodrine hydrochloride. There are thirteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.
Summary for 207613
Tradename:MIDODRINE HYDROCHLORIDE
Applicant:Unique Pharm Labs
Ingredient:midodrine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207613
Mechanism of ActionAdrenergic alpha-Agonists
Medical Subject Heading (MeSH) Categories for 207613
Suppliers and Packaging for NDA: 207613
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDODRINE HYDROCHLORIDE midodrine hydrochloride TABLET;ORAL 207613 ANDA Rising Pharmaceuticals, Inc. 64980-433 64980-433-01 100 TABLET in 1 BOTTLE (64980-433-01)
MIDODRINE HYDROCHLORIDE midodrine hydrochloride TABLET;ORAL 207613 ANDA Rising Pharmaceuticals, Inc. 64980-434 64980-434-01 100 TABLET in 1 BOTTLE (64980-434-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Nov 2, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 2, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 2, 2018TE:ABRLD:No

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