FDA.reportPublic FDA data

Application 018657

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLAGYL I.V. RTU IN PLASTIC CONTAINERMETRONIDAZOLEINJECTABLE;INJECTION500MG/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-1055MetronidazoleMetronidazoleBaxter Healthcare CorporationNDACurrent
0338-1055MetronidazoleMetronidazoleBaxter Healthcare CorporationNDACurrent
0338-1055MetronidazoleMetronidazoleBaxter Healthcare CorporationNDACurrent
0338-1055MetronidazoleMetronidazoleBaxter Healthcare CorporationNDACurrent
0338-1055MetronidazoleMetronidazoleBaxter Healthcare CorporationNDACurrent
0338-1055MetronidazoleMetronidazoleBaxter Healthcare CorporationNDACurrent
0338-9541MetronidazoleMetronidazoleBaxter Healthcare CorporationNDACurrent
0338-9541MetronidazoleMetronidazoleBaxter Healthcare CorporationNDACurrent
0338-9541MetronidazoleMetronidazoleBaxter Healthcare CorporationNDACurrent
0338-9541MetronidazoleMetronidazoleBaxter Healthcare CorporationNDACurrent
0338-9541MetronidazoleMetronidazoleBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82688SUPPL 2025-06-27
82664SUPPL 2025-06-25
81617SUPPL 2025-03-18
81613SUPPL 2025-03-17
79017SUPPL 2024-07-09
79004SUPPL 2024-07-09
69669SUPPL2021-12-20
69597SUPPL2021-12-16
66698SUPPL2021-03-09
66674SUPPL2021-03-09
50656SUPPL2017-12-12
50619SUPPL2017-12-06
33542SUPPL2015-07-16
1000SUPPL2015-07-14
15072SUPPL2013-10-25
11265SUPPL2013-10-25
15071SUPPL2012-05-30
11264SUPPL2011-08-12
999SUPPL2011-08-09
998SUPPL2009-11-19
11263SUPPL2009-09-17
33541SUPPL2004-06-07
15070SUPPL2004-06-07
11262SUPPL2004-06-07
997SUPPL2004-06-07