FDA.reportPublic FDA data

Application 020648

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIASTATDIAZEPAMGEL;RECTAL2.5MG/0.5ML (5MG/ML)YesNo
002DIASTATDIAZEPAMGEL;RECTAL5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003DIASTATDIAZEPAMGEL;RECTAL10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004DIASTATDIAZEPAMGEL;RECTAL15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005DIASTATDIAZEPAMGEL;RECTAL20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
006DIASTAT ACUDIALDIAZEPAMGEL;RECTAL20MG/4ML (5MG/ML)YesYes
007DIASTAT ACUDIALDIAZEPAMGEL;RECTAL10MG/2ML (5MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-6137DiazepamDiazepamTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-6138DiazepamDiazepamTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-6138DiazepamDiazepamTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-6139DiazepamDiazepamTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-6139DiazepamDiazepamTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0187-0658DiastatdiazepamBausch Health US LLCNDACurrent
0187-0658DiastatdiazepamBausch Health US, LLCNDACurrent
0187-0658DiastatdiazepamBausch Health US, LLCNDACurrent
0187-0658DiastatdiazepamValeant Pharmaceuticals North America LLCNDACurrent
0187-0658DiastatdiazepamBausch Health Americas, Inc.NDACurrent
0187-0658DiastatdiazepamBausch Health US, LLCNDACurrent
0187-0658DiastatdiazepamBausch Health US, LLCNDACurrent
0187-0658DiastatdiazepamBausch Health US, LLCNDACurrent
0187-0658DiastatdiazepamBausch Health US, LLCNDACurrent
0187-0659DiastatdiazepamBausch Health US, LLCNDACurrent
0187-0659DiastatdiazepamBausch Health US, LLCNDACurrent
0187-0659DiastatdiazepamValeant Pharmaceuticals North America LLCNDACurrent
0187-0659DiastatdiazepamBausch Health Americas, Inc.NDACurrent
0187-0659DiastatdiazepamBausch Health US, LLCNDACurrent
0187-0659DiastatdiazepamBausch Health US, LLCNDACurrent
0187-0659DiastatdiazepamBausch Health US, LLCNDACurrent
0187-0659DiastatdiazepamBausch Health US, LLCNDACurrent
0187-0659DiastatdiazepamBausch Health US LLCNDACurrent
66490-650DiastatdiazepamBausch Health US, LLCNDACurrent
66490-650DiastatdiazepamBausch Health US, LLCNDACurrent
66490-650DiastatdiazepamBausch Health US, LLCNDACurrent
66490-650DiastatdiazepamBausch Health US, LLCNDACurrent
66490-650DiastatdiazepamBausch Health US, LLCNDACurrent
66490-650DiastatdiazepamValeant Pharmaceuticals North America LLCNDACurrent
66490-650DiastatdiazepamBausch Health US, LLCNDACurrent
68682-650DiazepamDiazepamOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-650DiazepamDiazepamOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-650DiazepamDiazepamOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-650DiazepamDiazepamOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-652DiazepamdiazepamOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-652DiazepamdiazepamOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-652DiazepamdiazepamOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-652DiazepamdiazepamOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-655DiazepamDiazepamOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-655DiazepamDiazepamOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-655DiazepamDiazepamOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-655DiazepamDiazepamOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80487SUPPL 2024-12-04
80448SUPPL 2024-11-29
80447SUPPL 2024-11-29
73198SUPPL2023-01-17
73176SUPPL2023-01-17
66890SUPPL2021-03-26
66888SUPPL2021-03-26
66201SUPPL2021-02-12
66123SUPPL2021-02-09
46469SUPPL2016-12-22
46378SUPPL2016-12-21
46241SUPPL2016-12-20
45732SUPPL2016-10-31
35076SUPPL2014-12-17
25442SUPPL2014-12-17
25441SUPPL2013-09-03
20805SUPPL2007-07-06
23588ORIG2006-03-31
35075SUPPL2006-03-27
23060SUPPL2006-03-27
25440SUPPL2005-09-22
25439SUPPL2001-04-11