FDA.reportPublic FDA data

Application 075483

Type
ANDA
Sponsor
WOCKHARDT LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL2.5MGNoNo
002ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL5MGNoNo
003ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL10MGNoNo
004ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-4589ENALAPRIL MALEATEENALAPRIL MALEATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-4590ENALAPRIL MALEATEENALAPRIL MALEATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-4591ENALAPRIL MALEATEENALAPRIL MALEATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-4593ENALAPRIL MALEATEENALAPRIL MALEATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-5502ENALAPRIL MALEATEENALAPRIL MALEATEMajor PharmaceuticalsANDACurrent
0904-5502ENALAPRIL MALEATEENALAPRIL MALEATEMajor PharmaceuticalsANDACurrent
0904-5609ENALAPRIL MALEATEENALAPRIL MALEATEMajor PharmaceuticalsANDACurrent
0904-5609ENALAPRIL MALEATEENALAPRIL MALEATEMajor PharmaceuticalsANDACurrent
0904-5610ENALAPRIL MALEATEENALAPRIL MALEATEMajor PharmaceuticalsANDACurrent
0904-5610ENALAPRIL MALEATEENALAPRIL MALEATEMajor PharmaceuticalsANDACurrent
0904-5611ENALAPRIL MALEATEENALAPRIL MALEATEMajor PharmaceuticalsANDACurrent
0904-5611ENALAPRIL MALEATEENALAPRIL MALEATEMajor PharmaceuticalsANDACurrent
10544-170ENALAPRIL MALEATEENALAPRIL MALEATEBlenheim Pharmacal, Inc.ANDACurrent
21695-487ENALAPRIL MALEATEENALAPRIL MALEATERebel Distributors CorpANDACurrent
21695-488ENALAPRIL MALEATEENALAPRIL MALEATERebel Distributors CorpANDACurrent
21695-489ENALAPRIL MALEATEENALAPRIL MALEATERebel Distributors CorpANDACurrent
35356-869ENALAPRIL MALEATEENALAPRIL MALEATELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-869ENALAPRIL MALEATEENALAPRIL MALEATELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-871ENALAPRIL MALEATEENALAPRIL MALEATELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-871ENALAPRIL MALEATEENALAPRIL MALEATELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-871ENALAPRIL MALEATEENALAPRIL MALEATELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-871ENALAPRIL MALEATEENALAPRIL MALEATELake Erie Medical DBA Quality Care Products LLCANDACurrent
45865-404ENALAPRIL MALEATEENALAPRIL MALEATEMedsource PharmaceuticalsANDACurrent
50090-0689ENALAPRIL MALEATEENALAPRIL MALEATEA-S Medication SolutionsANDACurrent
50090-0689ENALAPRIL MALEATEENALAPRIL MALEATEA-S Medication SolutionsANDACurrent
50090-0689ENALAPRIL MALEATEENALAPRIL MALEATEA-S Medication SolutionsANDACurrent
50090-0690ENALAPRIL MALEATEENALAPRIL MALEATEA-S Medication SolutionsANDACurrent
50090-0690ENALAPRIL MALEATEENALAPRIL MALEATEA-S Medication SolutionsANDACurrent
50090-0690ENALAPRIL MALEATEENALAPRIL MALEATEA-S Medication SolutionsANDACurrent
50090-0692ENALAPRIL MALEATEENALAPRIL MALEATEA-S Medication SolutionsANDACurrent
50090-0692ENALAPRIL MALEATEENALAPRIL MALEATEA-S Medication SolutionsANDACurrent
50090-0692ENALAPRIL MALEATEENALAPRIL MALEATEA-S Medication SolutionsANDACurrent
50090-0692ENALAPRIL MALEATEENALAPRIL MALEATEA-S Medication SolutionsANDACurrent
50090-0692ENALAPRIL MALEATEENALAPRIL MALEATEA-S Medication SolutionsANDACurrent
50090-0692ENALAPRIL MALEATEENALAPRIL MALEATEA-S Medication SolutionsANDACurrent
50436-4353ENALAPRIL MALEATEENALAPRIL MALEATEUnit Dose ServicesANDACurrent
51138-033Enalapril MaleateEnalapril MaleateMed Health Pharma, LLCANDACurrent
51138-034Enalapril MaleateEnalapril MaleateMed Health Pharma, LLCANDACurrent
51138-035Enalapril MaleateEnalapril MaleateMed Health Pharma, LLCANDACurrent
51138-036Enalapril MaleateEnalapril MaleateMed Health Pharma, LLCANDACurrent
51655-279ENALAPRIL MALEATEENALAPRIL MALEATENorthwind Pharmaceuticals, LLCANDACurrent
53808-0242ENALAPRIL MALEATEENALAPRIL MALEATEState of Florida DOH Central PharmacyANDACurrent
53808-0243ENALAPRIL MALEATEENALAPRIL MALEATEState of Florida DOH Central PharmacyANDACurrent
53808-0244ENALAPRIL MALEATEENALAPRIL MALEATEState of Florida DOH Central PharmacyANDACurrent
53808-0966ENALAPRIL MALEATEENALAPRIL MALEATEState of Florida DOH Central PharmacyANDACurrent
55289-591ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, InANDACurrent
55289-591ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-591ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-591ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-591ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-591ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-694ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-694ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-694ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-694ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-694ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-984ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-984ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-984ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-984ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-984ENALAPRIL MALEATEENALAPRIL MALEATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
55648-923ENALAPRIL MALEATEENALAPRIL MALEATEWockhardt LimitedANDACurrent
55648-924ENALAPRIL MALEATEENALAPRIL MALEATEWockhardt LimitedANDACurrent
55648-925ENALAPRIL MALEATEENALAPRIL MALEATEWockhardt LimitedANDACurrent
55648-926ENALAPRIL MALEATEENALAPRIL MALEATEWockhardt LimitedANDACurrent
60760-226ENALAPRIL MALEATEENALAPRIL MALEATESt Marys Medical Park PharmacyANDACurrent
60760-226ENALAPRIL MALEATEENALAPRIL MALEATESt Marys Medical Park PharmacyANDACurrent
60760-226ENALAPRIL MALEATEENALAPRIL MALEATESt Marys Medical Park PharmacyANDACurrent
60760-227ENALAPRIL MALEATEENALAPRIL MALEATESt Marys Medical Park PharmacyANDACurrent
61919-277ENALAPRIL MALEATEENALAPRIL MALEATEDirectRXANDACurrent
61919-277ENALAPRIL MALEATEENALAPRIL MALEATEDirectRXANDACurrent
61919-277ENALAPRIL MALEATEENALAPRIL MALEATEDirectRXANDACurrent
61919-372ENALAPRIL MALEATEENALAPRIL MALEATEDIRECT RXANDACurrent
61919-372ENALAPRIL MALEATEENALAPRIL MALEATEDIRECT RXANDACurrent
61919-372ENALAPRIL MALEATEENALAPRIL MALEATEDIRECT RXANDACurrent
61919-372ENALAPRIL MALEATEENALAPRIL MALEATEDIRECT RXANDACurrent
61919-372ENALAPRIL MALEATEENALAPRIL MALEATEDirect_RxANDACurrent
61919-690ENALAPRIL MALEATEENALAPRIL MALEATEDIRECT RXANDACurrent
61919-690ENALAPRIL MALEATEENALAPRIL MALEATEDIRECT RXANDACurrent
61919-690ENALAPRIL MALEATEENALAPRIL MALEATEDIRECT RXANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30909ORIG2000-08-22