FDA.reportPublic FDA data

Application 202543

Type
NDA
Sponsor
HQ SPECIALITY PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS500MG/100ML (5MG/ML)YesYes
002LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS1000MG/100ML (10MG/ML)YesYes
003LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS1500MG/100ML (15MG/ML)YesYes
004LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS250MG/50ML (5MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44567-500LevetiracetamLevetiracetamWG Critical Care, LLCNDACurrent
44567-500LevetiracetamLevetiracetamWG Critical Care, LLCNDACurrent
44567-500LevetiracetamLevetiracetamWG Critical Care, LLCNDACurrent
44567-501LevetiracetamLevetiracetamWG Critical Care, LLCNDACurrent
44567-501LevetiracetamLevetiracetamWG Critical Care, LLCNDACurrent
44567-501LevetiracetamLevetiracetamWG Critical Care, LLCNDACurrent
44567-501LevetiracetamLevetiracetamWG Critical Care, LLCNDACurrent
44567-502LevetiracetamLevetiracetamWG Critical Care, LLCNDACurrent
44567-502LevetiracetamLevetiracetamWG Critical Care, LLCNDACurrent
44567-502LevetiracetamLevetiracetamWG Critical Care, LLCNDACurrent
44567-502LevetiracetamLevetiracetamWG Critical Care, LLCNDACurrent
44567-503LevetiracetamLevetiracetamWG Critical Care, LLCNDACurrent
44567-503LevetiracetamLevetiracetamWG Critical Care, LLCNDACurrent
44567-503LevetiracetamLevetiracetamWG Critical Care, LLCNDACurrent
67457-255LevetiracetamLevetiracetamMylan Institutional LLCNDACurrent
67457-255LevetiracetamLevetiracetamMylan Institutional LLCNDACurrent
67457-255LevetiracetamLevetiracetamMylan Institutional LLCNDACurrent
67457-255LevetiracetamLevetiracetamMylan Institutional LLCNDACurrent
67457-255LevetiracetamLevetiracetamMylan Institutional LLCNDACurrent
67457-265LevetiracetamLevetiracetamMylan Institutional LLCNDACurrent
67457-265LevetiracetamLevetiracetamMylan Institutional LLCNDACurrent
67457-265LevetiracetamLevetiracetamMylan Institutional LLCNDACurrent
67457-265LevetiracetamLevetiracetamMylan Institutional LLCNDACurrent
67457-265LevetiracetamLevetiracetamMylan Institutional LLCNDACurrent
67457-266LevetiracetamLevetiracetamMylan Institutional LLCNDACurrent
67457-266LevetiracetamLevetiracetamMylan Institutional LLCNDACurrent
67457-266LevetiracetamLevetiracetamMylan Institutional LLCNDACurrent
67457-266LevetiracetamLevetiracetamMylan Institutional LLCNDACurrent
67457-266LevetiracetamLevetiracetamMylan Institutional LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77816SUPPL 2024-03-13
77801SUPPL 2024-03-13
67075SUPPL2021-04-16
67053SUPPL2021-04-14
61032SUPPL2019-11-22
61026SUPPL2019-11-22
54898SUPPL2018-07-16
54876SUPPL2018-07-13
48712SUPPL2017-06-13
48708SUPPL2017-06-13
45920SUPPL2016-11-22
45919SUPPL2016-11-22
45935SUPPL2016-11-21
45934SUPPL2016-11-21
44861ORIG2012-06-14
43407ORIG2012-06-14
10070ORIG2011-11-14
40192ORIG2011-11-10