Application 020813

Type
NDA
Sponsor
ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KLONOPIN RAPIDLY DISINTEGRATINGCLONAZEPAMTABLET, ORALLY DISINTEGRATING;ORAL0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002KLONOPIN RAPIDLY DISINTEGRATINGCLONAZEPAMTABLET, ORALLY DISINTEGRATING;ORAL0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003KLONOPIN RAPIDLY DISINTEGRATINGCLONAZEPAMTABLET, ORALLY DISINTEGRATING;ORAL0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004KLONOPIN RAPIDLY DISINTEGRATINGCLONAZEPAMTABLET, ORALLY DISINTEGRATING;ORAL1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005KLONOPIN RAPIDLY DISINTEGRATINGCLONAZEPAMTABLET, ORALLY DISINTEGRATING;ORAL2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
46628SUPPL2016-12-30
46461SUPPL2016-12-22
46283SUPPL2016-12-20
3406SUPPL2013-11-06
35396SUPPL2013-11-01
25886SUPPL2011-12-05
3405SUPPL2010-09-21
3404SUPPL2010-09-21
35395SUPPL2010-09-07
13470SUPPL2010-09-07
13469SUPPL2009-05-12
25885SUPPL2009-05-01