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Last Updated: April 18, 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
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 017111

Antipsychotic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 017111

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

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