FDA.reportPublic FDA data

Application 076164

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LISINOPRILLISINOPRILTABLET;ORAL20MGNoNo
002LISINOPRILLISINOPRILTABLET;ORAL30MGNoNo
003LISINOPRILLISINOPRILTABLET;ORAL40MGNoNo
004LISINOPRILLISINOPRILTABLET;ORAL2.5MGNoNo
005LISINOPRILLISINOPRILTABLET;ORAL5MGNoNo
006LISINOPRILLISINOPRILTABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8064LisinoprilLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8064LisinoprilLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8065LisinoprilLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8065LisinoprilLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42708-096LISINOPRILLisinoprilQPharma IncANDACurrent
42708-096LISINOPRILLisinoprilQPharma IncANDACurrent
42708-096LISINOPRILLisinoprilQPharma IncANDACurrent
42708-142LISINOPRILLisinoprilQPharma IncANDACurrent
43063-786LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-786LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-786LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-786LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-786LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-786LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-786LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-786LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-800LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-800LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-800LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-800LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-800LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-297LISINOPRILLisinoprilAphena Pharma Solutions - Tennessee, LLCANDACurrent
43547-354LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-354LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-354LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-354LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-355LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-355LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-355LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-355LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-356LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-356LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-356LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-356LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
50090-2934LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-2934LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-3763LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-3763LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-3763LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-3763LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-4725LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-4725LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-4887LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-4887LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50436-0354LISINOPRILLisinoprilUnit Dose ServicesANDACurrent
50436-0354LISINOPRILLisinoprilUnit Dose ServicesANDACurrent
50436-0354LISINOPRILLisinoprilUnit Dose ServicesANDACurrent
50436-0354LISINOPRILLisinoprilUnit Dose ServicesANDACurrent
51655-335LISINOPRILLisinoprilNorthwind PharmaceuticalsANDACurrent
51655-335LISINOPRILLisinoprilNorthwind PharmaceuticalsANDACurrent
51655-411LISINOPRILLisinoprilNorthwind PharmaceuticalsANDACurrent
51655-411LISINOPRILLisinoprilNorthwind PharmaceuticalsANDACurrent
53002-1178LISINOPRILLisinoprilRPK Pharmaceuticals, Inc.ANDACurrent
53002-1178LISINOPRILLisinoprilRPK Pharmaceuticals, Inc.ANDACurrent
53002-1463LISINOPRILLisinoprilRPK Pharmaceuticals, Inc.ANDACurrent
53002-1463LISINOPRILLisinoprilRPK Pharmaceuticals, Inc.ANDACurrent
53217-322LISINOPRILLisinoprilAidarex Pharmaceuticals LLCANDACurrent
53217-333LISINOPRILLisinoprilAidarex Pharmaceuticals LLCANDACurrent
55700-480LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-480LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-480LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-480LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-480LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-480LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-480LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-480LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-480LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-547LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-547LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-547LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-547LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-558LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-558LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-359LISINOPRILLisinoprilSt. Mary's Medical Park PharmacyANDACurrent
60760-360LISINOPRILLisinoprilSt. Mary's Medical Park PharmacyANDACurrent
61919-246LisinoprilLisinoprilDirect_RxANDACurrent
61919-721LisinorilLisinoprilDirect_RxANDACurrent
61919-721LisinorilLisinoprilDirect_RxANDACurrent
61919-721LisinorilLisinoprilDirect_RxANDACurrent
61919-736LisinoprilLisinoprilDirect_RxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31091ORIG2003-04-11