FDA.reportPublic FDA data

Application 076180

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LISINOPRILLISINOPRILTABLET;ORAL2.5MGNoNo
002LISINOPRILLISINOPRILTABLET;ORAL5MGNoNo
003LISINOPRILLISINOPRILTABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8061LisinoprilLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8061LisinoprilLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8062LISINOPRILLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8062LISINOPRILLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8063LisinoprilLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8063LisinoprilLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42708-094LISINOPRILLisinoprilQPharma IncANDACurrent
42708-094LISINOPRILLisinoprilQPharma IncANDACurrent
42708-094LISINOPRILLisinoprilQPharma IncANDACurrent
43063-074LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-074LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-074LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-074LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-074LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-769LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-769LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-769LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-769LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-769LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-769LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-769LISINOPRILLisinoprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43547-351LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-351LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-351LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-351LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-352LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-352LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-352LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-352LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-353LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-353LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-353LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
43547-353LISINOPRILLisinoprilSolco healthcare U.S., LLCANDACurrent
50090-2431LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-2431LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-2431LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-2431LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-3765LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-3765LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-3765LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-3765LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-3765LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-3774LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-3774LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-3774LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-3774LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-4885LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50090-4885LISINOPRILLisinoprilA-S Medication SolutionsANDACurrent
50436-0352LISINOPRILLisinoprilUnit Dose ServicesANDACurrent
50436-0352LISINOPRILLisinoprilUnit Dose ServicesANDACurrent
50436-0352LISINOPRILLisinoprilUnit Dose ServicesANDACurrent
50436-0352LISINOPRILLisinoprilUnit Dose ServicesANDACurrent
50436-0353LISINOPRILLisinoprilUnit Dose ServicesANDACurrent
50436-0353LISINOPRILLisinoprilUnit Dose ServicesANDACurrent
50436-0353LISINOPRILLisinoprilUnit Dose ServicesANDACurrent
51655-399LISINOPRILLisinoprilNorthwind PharmaceuticalsANDACurrent
51655-399LISINOPRILLisinoprilNorthwind PharmaceuticalsANDACurrent
51655-399LISINOPRILLisinoprilNorthwind PharmaceuticalsANDACurrent
52959-854LISINOPRILLISINOPRILH. J. Harkins Company Inc.ANDACurrent
53002-1123LISINOPRILLisinoprilRPK Pharmaceuticals, Inc.ANDACurrent
53002-1123LISINOPRILLisinoprilRPK Pharmaceuticals, Inc.ANDACurrent
53002-1225LISINOPRILLisinoprilRPK Pharmaceuticals, Inc.ANDACurrent
53002-1225LISINOPRILLisinoprilRPK Pharmaceuticals, Inc.ANDACurrent
53217-202LISINOPRILLisinoprilAidarex Pharmaceuticals LLCANDACurrent
53217-303LISINOPRILLisinoprilAidarex Pharmaceuticals LLCANDACurrent
55700-479LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-479LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-479LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-479LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-479LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-479LISINOPRILLisinoprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-357LISINOPRILLisinoprilSt. Mary's Medical Park PharmacyANDACurrent
60760-358LISINOPRILLisinoprilSt. Mary's Medical Park PharmacyANDACurrent
61919-717LisinoprilLisinoprilDirect_RxANDACurrent
61919-746LISINOPRILLISINOPRILDirect_RxANDACurrent
61919-746LISINOPRILLISINOPRILDirect_RxANDACurrent
61919-746LISINOPRILLISINOPRILDirect_RxANDACurrent
61919-909LISINOPRILLISINOPRILDirect_RxANDACurrent
61919-909LISINOPRILLISINOPRILDirect_RxANDACurrent
61919-909LISINOPRILLISINOPRILDirect_RxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8873ORIG2003-04-11