FDA.reportPublic FDA data

Application 078203

Type
ANDA
Sponsor
LEADING PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORAZEPAMLORAZEPAMTABLET;ORAL0.5MGNoNo
002LORAZEPAMLORAZEPAMTABLET;ORAL1MGNoNo
003LORAZEPAMLORAZEPAMTABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8075LorazepamLorazepamNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8075LorazepamLorazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8076LorazepamLorazepamNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8076LorazepamLorazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8077LorazepamLorazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8077LorazepamLorazepamNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0904-6007LorazepamLorazepamMajor PharmaceuticalsANDACurrent
0904-6007LorazepamLorazepamMajor PharmaceuticalsANDACurrent
0904-6007LorazepamLorazepamMajor PharmaceuticalsANDACurrent
0904-6008LorazepamLorazepamMajor PharmaceuticalsANDACurrent
0904-6008LorazepamLorazepamMajor PharmaceuticalsANDACurrent
0904-6008LorazepamLorazepamMajor PharmaceuticalsANDACurrent
0904-6009LorazepamLorazepamMajor PharmaceuticalsANDACurrent
0904-6009LorazepamLorazepamMajor PharmaceuticalsANDACurrent
0904-6009LorazepamLorazepamMajor PharmaceuticalsANDACurrent
10544-269LorazepamLorazepamBlenheim Pharmacal, Inc.ANDACurrent
17856-2059LorazepamLorazepamATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-2059LorazepamLorazepamATLANTIC BIOLOGICALS CORP.ANDACurrent
33261-068LorazepamLorazepamAidarex Pharmaceuticals LLCANDACurrent
33261-069LorazepamLorazepamAidarex Pharmaceuticals LLCANDACurrent
33261-364LorazepamLorazepamAidarex Pharmaceuticals LLCANDACurrent
42254-096LorazepamLorazepamRebel Distributors CorpANDACurrent
42254-111LorazepamLorazepamRebel Distributors CorpANDACurrent
42254-113LorazepamLorazepamRebel Distributors CorpANDACurrent
43353-255LorazepamLorazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-2810LorazepamLorazepamA-S Medication SolutionsANDACurrent
50090-3510LorazepamLorazepamA-S Medication SolutionsANDACurrent
50090-5081LorazepamLorazepamA-S Medication SolutionsANDACurrent
50090-5508LorazepamLorazepamA-S Medication SolutionsANDACurrent
50090-5508LorazepamLorazepamA-S Medication SolutionsANDACurrent
50090-5509LorazepamLorazepamA-S Medication SolutionsANDACurrent
50090-5509LorazepamLorazepamA-S Medication SolutionsANDACurrent
53002-5291LorazepamLorazepamRPK Pharmaceuticals, Inc.ANDACurrent
53002-5291LorazepamLorazepamRPK Pharmaceuticals, Inc.ANDACurrent
53002-6290LorazepamLorazepamRPK Pharmaceuticals, Inc.ANDACurrent
53002-6290LorazepamLorazepamRPK Pharmaceuticals, Inc.ANDACurrent
53002-7721LorazepamLorazepamRPK Pharmaceuticals, Inc.ANDACurrent
53217-208LorazepamLorazepamAidarex Pharmaceuticals LLCANDACurrent
53217-216LorazepamLorazepamAidarex Pharmaceuticals LLCANDACurrent
54348-049LorazepamLORAZEPAMPharmPak, Inc.ANDACurrent
54348-049LorazepamLORAZEPAMPharmPak, Inc.ANDACurrent
55154-7975LorazepamLorazepamCardinal Health 107, LLCANDACurrent
55154-7975LorazepamLorazepamCardinal HealthANDACurrent
55154-7976LorazepamLorazepamCardinal HealthANDACurrent
55154-7976LorazepamLorazepamCardinal Health 107, LLCANDACurrent
55154-7976LorazepamLorazepamCardinal HealthANDACurrent
55154-7977LorazepamLorazepamCardinal Health 107, LLCANDACurrent
55700-614LorazepamLorazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-745LorazepamLorazepamQuality Care Products, LLCANDACurrent
55700-778LorazepamLorazepamQuality Care Products, LLCANDACurrent
55700-778LorazepamLorazepamQuality Care Products, LLCANDACurrent
58118-0904LorazepamLorazepamClinical Solutions Wholesale, LLCANDACurrent
58118-0904LorazepamLorazepamClinical Solutions Wholesale, LLCANDACurrent
58118-0904LorazepamLorazepamClinical Solutions Wholesale, LLCANDACurrent
58118-1095LorazepamLorazepamClinical Solutions Wholesale, LLCANDACurrent
58118-1095LorazepamLorazepamClinical Solutions Wholesale, LLCANDACurrent
58118-1095LorazepamLorazepamClinical Solutions Wholesale, LLCANDACurrent
58118-1096LorazepamLorazepamClinical Solutions Wholesale, LLCANDACurrent
58118-1096LorazepamLorazepamClinical Solutions Wholesale, LLCANDACurrent
58118-1096LorazepamLorazepamClinical Solutions Wholesale, LLCANDACurrent
60760-516LorazepamLorazepamSt. Mary's Medical Park PharmacyANDACurrent
60760-516LorazepamLorazepamSt. Mary's Medical Park PharmacyANDACurrent
61919-062LORAZEPAMLORAZEPAMDIRECT RXANDACurrent
61919-062LorazepamLorazepamDirect_RxANDACurrent
61919-062LorazepamLorazepamDirect_RxANDACurrent
61919-062LorazepamLorazepamDirect_RxANDACurrent
61919-062LORAZEPAMLORAZEPAMDIRECT RXANDACurrent
61919-062LORAZEPAMLORAZEPAMDIRECT RXANDACurrent
61919-062LorazepamLorazepamDirect_RxANDACurrent
61919-143LORAZEPAMLORAZEPAMDIRECTRXANDACurrent
61919-607LORAZEPAMLORAZEPAMDirectRXANDACurrent
61919-607LORAZEPAMLORAZEPAMDirectRXANDACurrent
61919-607LORAZEPAMLORAZEPAMDirectRXANDACurrent
61919-607LORAZEPAMLORAZEPAMDirectRXANDACurrent
63739-802LorazepamLorazepamMcKesson Corporation dba SKY PackagingANDACurrent
63739-802LorazepamLorazepamMcKesson CorporationANDACurrent
63739-803LorazepamLorazepamMcKesson Corporation dba SKY PackagingANDACurrent
63739-803LorazepamLorazepamMcKesson CorporationANDACurrent
63739-804LorazepamLorazepamMcKesson Corporation dba SKY PackagingANDACurrent
63739-804LorazepamLorazepamMcKesson CorporationANDACurrent