FDA.reportPublic FDA data

Application 065397

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
002VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-424Sterile Vancomycin HydrochlorideVancomycin HydrochlorideRebel Distributors CorpANDACurrent
67457-339Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCANDACurrent
67457-339Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCANDACurrent
67457-340Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCANDACurrent
67457-340Vancomycin HydrochlorideVancomycin HydrochlorideMylan Institutional LLCANDACurrent
67457-611vancomycin hydrochloridevancomycin hydrochlorideMylan Institutional LLCANDACurrent
67457-611vancomycin hydrochloridevancomycin hydrochlorideMylan Institutional LLCANDACurrent
67457-611vancomycin hydrochloridevancomycin hydrochlorideMylan Institutional LLCANDACurrent
67457-612vancomycin hydrochloridevancomycin hydrochlorideMylan Institutional LLCANDACurrent
67457-612vancomycin hydrochloridevancomycin hydrochlorideMylan Institutional LLCANDACurrent
67457-612vancomycin hydrochloridevancomycin hydrochlorideMylan Institutional LLCANDACurrent
82449-803Vancomycin HydrochlorideVancomycin HydrochlorideSTERISCIENCE SPECIALTIES PRIVATE LIMITEDANDACurrent
82449-804Vancomycin HydrochlorideVancomycin HydrochlorideSTERISCIENCE SPECIALTIES PRIVATE LIMITEDANDACurrent