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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 090453


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NDA 090453 describes MOLINDONE HYDROCHLORIDE, which is a drug marketed by Epic Pharma Llc and is included in one NDA. It is available from one supplier. Additional details are available on the MOLINDONE HYDROCHLORIDE profile page.

The generic ingredient in MOLINDONE HYDROCHLORIDE is molindone hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the molindone hydrochloride profile page.
Summary for 090453
Tradename:MOLINDONE HYDROCHLORIDE
Applicant:Epic Pharma Llc
Ingredient:molindone hydrochloride
Patents:0
Pharmacology for NDA: 090453
Medical Subject Heading (MeSH) Categories for 090453
Antipsychotic Agents
Suppliers and Packaging for NDA: 090453
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MOLINDONE HYDROCHLORIDE molindone hydrochloride TABLET;ORAL 090453 ANDA EPIC PHARMA, LLC 42806-336 42806-336-01 100 TABLET in 1 BOTTLE (42806-336-01)
MOLINDONE HYDROCHLORIDE molindone hydrochloride TABLET;ORAL 090453 ANDA EPIC PHARMA, LLC 42806-337 42806-337-01 100 TABLET in 1 BOTTLE (42806-337-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 20, 2015TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 20, 2015TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Mar 20, 2015TE:RLD:No

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Preferred Citation:

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