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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218628


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NDA 218628 describes BUCAPSOL, which is a drug marketed by Epic Pharma Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the BUCAPSOL profile page.

The generic ingredient in BUCAPSOL is buspirone hydrochloride. There are nineteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.
Summary for 218628
Tradename:BUCAPSOL
Applicant:Epic Pharma Llc
Ingredient:buspirone hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 218628
Anti-Anxiety Agents
Serotonin Receptor Agonists
Suppliers and Packaging for NDA: 218628
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUCAPSOL buspirone hydrochloride CAPSULE;ORAL 218628 ANDA EPIC PHARMA, LLC 42806-831 42806-831-01 100 CAPSULE in 1 BOTTLE (42806-831-01)
BUCAPSOL buspirone hydrochloride CAPSULE;ORAL 218628 ANDA EPIC PHARMA, LLC 42806-832 42806-832-01 100 CAPSULE in 1 BOTTLE (42806-832-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength7.5MG
Approval Date:Mar 13, 2025TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Mar 13, 2025TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Mar 13, 2025TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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