FDA.reportPublic FDA data

Application 205694

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
002VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
003VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 5GM BASE/VIALNoNo
004VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 10GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-597Vancomycin Hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent
47781-597Vancomycin Hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent
47781-597Vancomycin Hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent
47781-598Vancomycin Hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent
47781-598Vancomycin Hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent
47781-598Vancomycin Hydrochloridevancomycin hydrochlorideAlvogen Inc.ANDACurrent
51991-940Vancomycin HydrochlorideVancomycinBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-940Vancomycin HydrochlorideVancomycinBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-941Vancomycin HydrochlorideVancomycinBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-941Vancomycin HydrochlorideVancomycinBreckenridge Pharmaceutical, Inc.ANDACurrent
68001-338Vancomycin HydrochlorideVancomycinBluePoint LaboratoriesANDACurrent
68001-338Vancomycin HydrochlorideVancomycinBluePoint LaboratoriesANDACurrent
68001-339Vancomycin HydrochlorideVancomycinBluePoint LaboratoriesANDACurrent
68001-339Vancomycin HydrochlorideVancomycinBluePoint LaboratoriesANDACurrent
68083-143Vancomycin HydrochlorideVancomycin HydrochlorideGland Pharma LimitedANDACurrent
68083-143Vancomycin HydrochlorideVancomycin HydrochlorideGland Pharma LimitedANDACurrent
68083-144Vancomycin HydrochlorideVancomycin HydrochlorideGland Pharma LimitedANDACurrent
68083-144Vancomycin HydrochlorideVancomycin HydrochlorideGland Pharma LimitedANDACurrent
70860-104Vancomycin Hydrochloridevancomycin hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-105Vancomycin Hydrochloridevancomycin hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
72611-761Vancomycin Hydrochloridevancomycin hydrochlorideAlmaject, Inc.ANDACurrent
72611-761Vancomycin Hydrochloridevancomycin hydrochlorideAlmaject, Inc.ANDACurrent
72611-761Vancomycin Hydrochloridevancomycin hydrochlorideAlmaject, Inc.ANDACurrent
72611-765Vancomycin Hydrochloridevancomycin hydrochlorideAlmaject, Inc.ANDACurrent
72611-765Vancomycin Hydrochloridevancomycin hydrochlorideAlmaject, Inc.ANDACurrent
72611-765Vancomycin Hydrochloridevancomycin hydrochlorideAlmaject, Inc.ANDACurrent