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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 017111


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NDA 017111 describes MOBAN, which is a drug marketed by Chartwell Rx and Endo Pharms and is included in two NDAs. Additional details are available on the MOBAN profile page.

The generic ingredient in MOBAN 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 017111
Tradename:MOBAN
Applicant:Chartwell Rx
Ingredient:molindone hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 017111

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 017111

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chartwell Rx MOBAN molindone hydrochloride TABLET;ORAL 017111-007 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Chartwell Rx MOBAN molindone hydrochloride TABLET;ORAL 017111-004 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Chartwell Rx MOBAN molindone hydrochloride TABLET;ORAL 017111-006 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Chartwell Rx MOBAN molindone hydrochloride TABLET;ORAL 017111-005 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Chartwell Rx MOBAN molindone hydrochloride TABLET;ORAL 017111-008 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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