FDA.report

Application 201406

Type
ANDA
Sponsor
ANTIBIOTICE

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALNoNo
002AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
36000-094Ampicillin and SulbactamAmpicillin sodium and sulbactam sodiumClaris Life Sciences Inc.ANDACurrent
36000-095Ampicillin and SulbactamAmpicillin sodium and sulbactam sodiumClaris Life Sciences Inc.ANDACurrent
44567-150Ampicillin and SulbactamAmpicillin and SulbactamWG Critical Care, LLCANDACurrent
44567-150Ampicillin and SulbactamAmpicillin and SulbactamWG Critical Care, LLCANDACurrent
67850-130AMPICILLIN and SULBACTAMAmpicillin and Sulbactam for injectionMethapharm, Inc.ANDACurrent
67850-130AMPICILLIN and SULBACTAMAmpicillin and Sulbactam for injectionMethapharm, Inc.ANDACurrent
67850-131AMPICILLIN and SULBACTAMAmpicillin and Sulbactam for injectionMethapharm, Inc.ANDACurrent

Documents

DocumentSubmission typeDate
9893ORIG2015-12-10