FDA.reportPublic FDA data

Application 017794

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATIVANLORAZEPAMTABLET;ORAL0.5MGYesNo
002ATIVANLORAZEPAMTABLET;ORAL1MGYesNo
003ATIVANLORAZEPAMTABLET;ORAL2MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0063AtivanlorazepamBausch Health US LLCNDACurrent
0187-0063AtivanlorazepamBausch Health US LLCNDACurrent
0187-0063AtivanlorazepamValeant Pharmaceuticals North America LLCNDACurrent
0187-0063AtivanlorazepamBausch Health US LLCNDACurrent
0187-0063AtivanlorazepamBausch Health Americas, Inc.NDACurrent
0187-0063AtivanlorazepamBausch Health US LLCNDACurrent
0187-0063AtivanlorazepamBausch Health US, LLCNDACurrent
0187-0063AtivanlorazepamBausch Health US LLCNDACurrent
0187-0063AtivanlorazepamBausch Health US LLCNDACurrent
0187-0063AtivanlorazepamBausch Health US LLCNDACurrent
0187-0064AtivanlorazepamBausch Health Americas, Inc.NDACurrent
0187-0064AtivanlorazepamBausch Health US LLCNDACurrent
0187-0064AtivanlorazepamBausch Health US LLCNDACurrent
0187-0064AtivanlorazepamBausch Health US, LLCNDACurrent
0187-0064AtivanlorazepamBausch Health US LLCNDACurrent
0187-0064AtivanlorazepamBausch Health US LLCNDACurrent
0187-0064AtivanlorazepamValeant Pharmaceuticals North America LLCNDACurrent
0187-0064AtivanlorazepamBausch Health US LLCNDACurrent
0187-0064AtivanlorazepamBausch Health US LLCNDACurrent
0187-0064AtivanlorazepamBausch Health US LLCNDACurrent
0187-0065AtivanlorazepamBausch Health US LLCNDACurrent
0187-0065AtivanlorazepamBausch Health US LLCNDACurrent
0187-0065AtivanlorazepamBausch Health US LLCNDACurrent
0187-0065AtivanlorazepamValeant Pharmaceuticals North America LLCNDACurrent
0187-0065AtivanlorazepamBausch Health US LLCNDACurrent
0187-0065AtivanlorazepamBausch Health Americas, Inc.NDACurrent
0187-0065AtivanlorazepamBausch Health US LLCNDACurrent
0187-0065AtivanlorazepamBausch Health US, LLCNDACurrent
0187-0065AtivanlorazepamBausch Health US LLCNDACurrent
0187-0065AtivanlorazepamBausch Health US LLCNDACurrent
65084-463AtivanlorazepamMckesson Rxpak IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73225SUPPL2023-01-17
73224SUPPL2023-01-17
73168SUPPL2023-01-17
66184SUPPL2021-02-11
66183SUPPL2021-02-11
66127SUPPL2021-02-09
46629SUPPL2016-12-30
46462SUPPL2016-12-22
46238SUPPL2016-12-20
705SUPPL2007-04-25
11063SUPPL2007-04-20