FDA.reportPublic FDA data

Application 020630

Type
NDA
Sponsor
MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ULTIVAREMIFENTANIL HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1MG BASE/VIALYesNo
002ULTIVAREMIFENTANIL HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2MG BASE/VIALYesNo
003ULTIVAREMIFENTANIL HYDROCHLORIDEINJECTABLE;INJECTIONEQ 5MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-198UltivaRemifentanil HydrochlorideMylan Institutional LLCNDACurrent
67457-198UltivaRemifentanil HydrochlorideMylan Institutional LLCNDACurrent
67457-198UltivaRemifentanil HydrochlorideMylan Institutional LLCNDACurrent
67457-198UltivaRemifentanil HydrochlorideMylan Institutional LLCNDACurrent
67457-912UltivaRemifentanil HydrochlorideMylan Institutional LLCNDACurrent
67457-912UltivaRemifentanil HydrochlorideMylan Institutional LLCNDACurrent
67457-913UltivaRemifentanil HydrochlorideMylan Institutional LLCNDACurrent
67457-913UltivaRemifentanil HydrochlorideMylan Institutional LLCNDACurrent
67457-914UltivaRemifentanil HydrochlorideMylan Institutional LLCNDACurrent
67457-914UltivaRemifentanil HydrochlorideMylan Institutional LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84644SUPPL 2026-01-05
84643SUPPL 2026-01-05
84600SUPPL 2025-12-31
84599SUPPL 2025-12-31
77029SUPPL 2023-12-19
76954SUPPL 2023-12-18
60569SUPPL2019-10-15
60422SUPPL2019-10-09
57681ORIG2019-02-15
54746SUPPL2018-07-04
46376SUPPL2016-12-21
46255SUPPL2016-12-20
12873SUPPL2004-04-05
25357SUPPL2004-03-10