FDA.reportPublic FDA data

Application 071250

Type
ANDA
Sponsor
IMPAX LABS INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1651Metoclopramide HydrochlorideMetoclopramide HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1651Metoclopramide HydrochlorideMetoclopramide HydrochlorideImpax GenericsANDACurrent
0115-1651Metoclopramide HydrochlorideMetoclopramide HydrochlorideImpax GenericsANDACurrent
0615-8038Metoclopramide HydrochlorideMetoclopramide HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8071Metoclopramide HydrochlorideMetoclopramide HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-346MetoclopramideMetoclopramideRebel Distributors Corp.ANDACurrent
42254-266Metoclopramide HydrochlorideMetoclopramide HydrochlorideRebel Distributors CorpANDACurrent
43353-808Metoclopramide HydrochlorideMetoclopramide HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
53808-0623Metoclopramide HydrochlorideMetoclopramide HydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0722MetoclopramideMetoclopramideState of Florida DOH Central PharmacyANDACurrent
55154-6848Metoclopramide HydrochlorideMetoclopramide HydrochlorideCardinal HealthANDACurrent
63739-293Metoclopramide HydrochlorideMetoclopramide HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-293Metoclopramide HydrochlorideMetoclopramide HydrochlorideMcKesson CorporationANDACurrent
67296-0880Metoclopramide HydrochlorideMetoclopramide HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0880Metoclopramide HydrochlorideMetoclopramide HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0883Metoclopramide HydrochlorideMetoclopramide HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0883Metoclopramide HydrochlorideMetoclopramide HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1810Metoclopramide HydrochlorideMetoclopramide HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-3031Metoclopramide HydrochlorideMetoclopramide HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3262Metoclopramide HydrochlorideMetoclopramide HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3262Metoclopramide HydrochlorideMetoclopramide HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6791Metoclopramide HydrochlorideMetoclopramide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6791Metoclopramide HydrochlorideMetoclopramide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6791Metoclopramide HydrochlorideMetoclopramide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6791Metoclopramide HydrochlorideMetoclopramide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9706Metoclopramide HydrochlorideMetoclopramide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
71335-0522Metoclopramide HydrochlorideMetoclopramide HydrochlorideBryant Ranch PrepackANDACurrent
71335-0522Metoclopramide HydrochlorideMetoclopramide HydrochlorideBryant Ranch PrepackANDACurrent