FDA.reportPublic FDA data

Application 077580

Type
ANDA
Sponsor
ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HALOPERIDOLHALOPERIDOLTABLET; ORAL5MGNoNo
002HALOPERIDOLHALOPERIDOLTABLET;ORAL1MGNoNo
003HALOPERIDOLHALOPERIDOLTABLET;ORAL5MGNoNo
004HALOPERIDOLHALOPERIDOLTABLET;ORAL10MGNoNo
005HALOPERIDOLHALOPERIDOLTABLET;ORAL20MGNoNo
006HALOPERIDOLHALOPERIDOLTABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6661HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
0904-6661HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
0904-6661HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
0904-6661HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
0904-6661HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
0904-6733HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
0904-6733HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
0904-6733HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
0904-6782HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
0904-6782HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
0904-6782HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
0904-6782HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
50090-3376HaloperidolHaloperidolA-S Medication SolutionsANDACurrent
50090-4365HaloperidolHaloperidolA-S Medication SolutionsANDACurrent
50090-4365HaloperidolHaloperidolA-S Medication SolutionsANDACurrent
50090-4365HaloperidolHaloperidolA-S Medication SolutionsANDACurrent
50268-391HaloperidolHaloperidolAvPAKANDACurrent
50268-392HaloperidolHaloperidolAvPAKANDACurrent
50268-392HaloperidolHaloperidolAvPAKANDACurrent
50268-392HaloperidolHaloperidolAvPAKANDACurrent
50268-392HaloperidolHaloperidolAvPAKANDACurrent
50268-393HaloperidolHaloperidolAvPAKANDACurrent
50268-393HaloperidolHaloperidolAvPAKANDACurrent
50436-0233HaloperidolHaloperidolUnit Dose ServicesANDACurrent
55154-3566HaloperidolHaloperidolCardinal Health 107, LLCANDACurrent
55154-3566HaloperidolHaloperidolCardinal HealthANDACurrent
58118-1079HaloperidolHaloperidolClinical Solutions Wholesale, LLCANDACurrent
58118-1079HaloperidolHaloperidolClinical Solutions Wholesale, LLCANDACurrent
60687-161HaloperidolHaloperidolAmerican Health PackagingANDACurrent
60687-161HaloperidolHaloperidolAmerican Health PackagingANDACurrent
60687-161HaloperidolHaloperidolAmerican Health PackagingANDACurrent
60687-161HaloperidolHaloperidolAmerican Health PackagingANDACurrent
61919-133HALOPERIDOLHALOPERIDOLDIRECT RXANDACurrent
61919-133HALOPERIDOLHALOPERIDOLDIRECT RXANDACurrent
64725-0080HaloperidolHaloperidolTYA PharmaceuticalsANDACurrent
65841-626HaloperidolHaloperidolCadila Healthcare LimitedANDACurrent
65841-626HaloperidolHaloperidolCadila Healthcare LimitedANDACurrent
65841-626HaloperidolHaloperidolZydus Lifesciences LimitedANDACurrent
65841-626HaloperidolHaloperidolCadila Healthcare LimitedANDACurrent
65841-627HaloperidolHaloperidolCadila Healthcare LimitedANDACurrent
65841-627HaloperidolHaloperidolCadila Healthcare LimitedANDACurrent
65841-627HaloperidolHaloperidolZydus Lifesciences LimitedANDACurrent
65841-627HaloperidolHaloperidolCadila Healthcare LimitedANDACurrent
65841-628HaloperidolHaloperidolCadila Healthcare LimitedANDACurrent
65841-628HaloperidolHaloperidolZydus Lifesciences LimitedANDACurrent
65841-628HaloperidolHaloperidolCadila Healthcare LimitedANDACurrent
65841-628HaloperidolHaloperidolCadila Healthcare LimitedANDACurrent
67046-329HaloperidolHaloperidolContract Pharmacy Services-PAANDACurrent
68084-249HaloperidolHaloperidolAmerican Health PackagingANDACurrent
68084-249HaloperidolHaloperidolAmerican Health PackagingANDACurrent
68084-249HaloperidolHaloperidolAmerican Health PackagingANDACurrent
68084-249HaloperidolHaloperidolAmerican Health PackagingANDACurrent
68084-250HaloperidolHaloperidolAmerican Health PackagingANDACurrent
68084-250HaloperidolHaloperidolAmerican Health PackagingANDACurrent
68084-250HaloperidolHaloperidolAmerican Health PackagingANDACurrent
68084-250HaloperidolHaloperidolAmerican Health PackagingANDACurrent
68382-079HaloperidolHaloperidolZydus Pharmaceuticals USA Inc.ANDACurrent
68382-079HaloperidolHaloperidolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-079HaloperidolHaloperidolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-079HaloperidolHaloperidolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-080HaloperidolHaloperidolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-080HaloperidolHaloperidolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-080HaloperidolHaloperidolZydus Pharmaceuticals USA Inc.ANDACurrent
68382-080HaloperidolHaloperidolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-081HaloperidolHaloperidolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-081HaloperidolHaloperidolZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-081HaloperidolHaloperidolZydus Pharmaceuticals USA Inc.ANDACurrent
68382-081HaloperidolHaloperidolZydus Pharmaceuticals (USA) Inc.ANDACurrent
70518-0831HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-0831HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-0831HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-0831HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-0831HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-0831HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-1182HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-1182HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-1182HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-1182HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-1182HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-1269HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44619ORIG2007-12-03