FDA.reportPublic FDA data

Application 012750

Type
NDA
Sponsor
VALEANT PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIBRAXCHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDECAPSULE;ORAL5MG;2.5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-4100LibraxChlordiazepoxide Hydrochloride and Clidinium BromideBausch Health US LLCNDACurrent
0187-4100LibraxChlordiazepoxide Hydrochloride and Clidinium BromideBausch Health US LLCNDACurrent
0187-4100LibraxChlordiazepoxide Hydrochloride and Clidinium BromideBausch Health US LLCNDACurrent
0187-4100LibraxChlordiazepoxide Hydrochloride and Clidinium BromideBausch Health Americas, Inc.NDACurrent
0187-4100LibraxChlordiazepoxide Hydrochloride and Clidinium BromideValeant Pharmaceuticals InternationalNDACurrent
0187-4100LibraxChlordiazepoxide Hydrochloride and Clidinium BromideBausch Health US LLCNDACurrent
0187-4100LibraxChlordiazepoxide Hydrochloride and Clidinium BromideBausch Health US LLCNDACurrent
42494-409Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideCameron Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
42494-409Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideCameron Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
42494-409Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideCameron Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
50090-1528Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
63629-2146Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2146Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
68151-2500Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
69189-0489Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium BromideAvera McKennan HospitalNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73215SUPPL2023-01-17
73214SUPPL2023-01-17
73163SUPPL2023-01-17
66162SUPPL2021-02-09
66161SUPPL2021-02-09
66136SUPPL2021-02-09
46901SUPPL2017-01-19
46900SUPPL2017-01-19
46860SUPPL2017-01-13
46456SUPPL2016-12-22