FDA.reportPublic FDA data

Application 212332

Type
ANDA
Sponsor
HAINAN POLY PHARM

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
70436-020VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESlate Run Pharmaceuticals, LLCANDACurrent
70436-020VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESlate Run Pharmaceuticals, LLCANDACurrent
70436-020VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESlate Run Pharmaceuticals, LLCANDACurrent
70436-020VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESlate Run Pharmaceuticals, LLCANDACurrent
70436-021VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESlate Run Pharmaceuticals, LLCANDACurrent
70436-021VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESlate Run Pharmaceuticals, LLCANDACurrent
70436-021VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESlate Run Pharmaceuticals, LLCANDACurrent
70436-021VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESlate Run Pharmaceuticals, LLCANDACurrent