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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 217268


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NDA 217268 describes PRAZOSIN HYDROCHLORIDE, which is a drug marketed by Alembic, Am Therap, Ani Pharms, Appco, Aurobindo Pharma Ltd, Dava Pharms Inc, Granules, Lannett Co Inc, Mankind Pharma, MSN, Mylan, Novitium Pharma, Purepac Pharm, Teva Pharms, and Watson Labs, and is included in twenty-three NDAs. It is available from twenty-eight suppliers. Additional details are available on the PRAZOSIN HYDROCHLORIDE profile page.

The generic ingredient in PRAZOSIN HYDROCHLORIDE is prazosin hydrochloride. There are seventeen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the prazosin hydrochloride profile page.
Summary for 217268
Tradename:PRAZOSIN HYDROCHLORIDE
Applicant:Alembic
Ingredient:prazosin hydrochloride
Patents:0
Pharmacology for NDA: 217268
Mechanism of ActionAdrenergic alpha-Antagonists
Medical Subject Heading (MeSH) Categories for 217268
Suppliers and Packaging for NDA: 217268
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAZOSIN HYDROCHLORIDE prazosin hydrochloride CAPSULE;ORAL 217268 ANDA Alembic Pharmaceuticals Limited 46708-691 46708-691-31 100 CAPSULE in 1 BOTTLE (46708-691-31)
PRAZOSIN HYDROCHLORIDE prazosin hydrochloride CAPSULE;ORAL 217268 ANDA Alembic Pharmaceuticals Limited 46708-691 46708-691-61 250 CAPSULE in 1 BOTTLE (46708-691-61)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Mar 6, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 2MG BASE
Approval Date:Mar 6, 2023TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Mar 6, 2023TE:ABRLD:No

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