FDA.reportPublic FDA data

Application 202191

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDETABLET, ORALLY DISINTEGRATING;ORALEQ 5MG BASENoNo
002METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDETABLET, ORALLY DISINTEGRATING;ORALEQ 10MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-580METOCLOPRAMIDE hydrochlorideMetoclopramide HydrochlorideNovel Laboratories, Inc.ANDACurrent
40032-581METOCLOPRAMIDE hydrochlorideMetoclopramide HydrochlorideNovel Laboratories, Inc.ANDACurrent
43386-580METOCLOPRAMIDE hydrochlorideMetoclopramide HydrochlorideGAVIS Pharmaceuticals, LLCANDACurrent
43386-580METOCLOPRAMIDE hydrochlorideMetoclopramide HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-580METOCLOPRAMIDE hydrochlorideMetoclopramide HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-580METOCLOPRAMIDE hydrochlorideMetoclopramide HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-581METOCLOPRAMIDE hydrochlorideMetoclopramide HydrochlorideGAVIS Pharmaceuticals, LLCANDACurrent
43386-581METOCLOPRAMIDE hydrochlorideMetoclopramide HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-581METOCLOPRAMIDE hydrochlorideMetoclopramide HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-581METOCLOPRAMIDE hydrochlorideMetoclopramide HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32201ORIG2014-08-19