FDA.reportPublic FDA data

Application 071402

Type
ANDA
Sponsor
ANI PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDESOLUTION;ORALEQ 5MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62559-190MetoclopramideMetoclopramideANI Pharmaceuticals, Inc.ANDACurrent
62559-190MetoclopramideMetoclopramideANI Pharmaceuticals, Inc.ANDACurrent
63629-1961MetoclopramideMetoclopramideBryant Ranch PrepackANDACurrent
63629-1961MetoclopramideMetoclopramideBryant Ranch PrepackANDACurrent
63629-2144MetoclopramideMetoclopramideBryant Ranch PrepackANDACurrent
63629-2144MetoclopramideMetoclopramideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42824SUPPL2011-12-02
42823SUPPL2011-12-02