FDA.reportPublic FDA data

Application 209481

Type
NDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEPOWDER;INTRAVENOUSEQ 250MG BASE/VIALYesYes
002VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEPOWDER;INTRAVENOUSEQ 750MG BASE/VIALYesYes
003VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEPOWDER;INTRAVENOUSEQ 1.25GM BASE/VIALYesYes
004VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEPOWDER;INTRAVENOUSEQ 1.5GM BASE/VIALYesYes
005VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEPOWDER;INTRAVENOUSEQ 1.75GM BASE/VIALYesYes
006VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEPOWDER;INTRAVENOUSEQ 2GM BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-705Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCNDACurrent
67457-705Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCNDACurrent
67457-705Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCNDACurrent
67457-705Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCNDACurrent
67457-822Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCNDACurrent
67457-822Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCNDACurrent
67457-822Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCNDACurrent
67457-823Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCNDACurrent
67457-823Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCNDACurrent
67457-823Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCNDACurrent
67457-823Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCNDACurrent
67457-824Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCNDACurrent
67457-824Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCNDACurrent
67457-824Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCNDACurrent
67457-824Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78920SUPPL 2024-06-27
78908SUPPL 2024-06-27
70703SUPPL2022-04-05
70695SUPPL2022-04-05
66050SUPPL2021-02-01
66033SUPPL2021-02-01
59678SUPPL2019-08-13
59660SUPPL2019-08-12
57125ORIG2019-01-07
54889ORIG2018-07-16
54867ORIG2018-07-11