Application 017111

Type
NDA
Sponsor
ENDO PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001MOBANMOLINDONE HYDROCHLORIDECAPSULE;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002MOBANMOLINDONE HYDROCHLORIDECAPSULE;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003MOBANMOLINDONE HYDROCHLORIDECAPSULE;ORAL25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004MOBANMOLINDONE HYDROCHLORIDETABLET;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005MOBANMOLINDONE HYDROCHLORIDETABLET;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
006MOBANMOLINDONE HYDROCHLORIDETABLET;ORAL25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
007MOBANMOLINDONE HYDROCHLORIDETABLET;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
008MOBANMOLINDONE HYDROCHLORIDETABLET;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents

DocumentSubmission typeDate
81145SUPPL 2025-02-07
81012SUPPL 2025-02-05
47398SUPPL2017-03-02
47354SUPPL2017-02-27
13092SUPPL2010-12-06
10970SUPPL2010-12-04
33231SUPPL2009-07-23
555SUPPL2009-07-23
33230SUPPL2008-08-29
554SUPPL2008-08-19
33229SUPPL2008-03-17
13091SUPPL2008-03-17
553SUPPL2003-04-09