FDA.reportPublic FDA data

Application 018998

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VASOTECENALAPRIL MALEATETABLET;ORAL5MGYesNo
002VASOTECENALAPRIL MALEATETABLET;ORAL10MGYesNo
003VASOTECENALAPRIL MALEATETABLET;ORAL20MGYesYes
005VASOTECENALAPRIL MALEATETABLET;ORAL2.5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0140VasotecEnalapril MaleateBausch Health US LLCNDACurrent
0187-0140VasotecEnalapril MaleateBausch Health US LLCNDACurrent
0187-0140VasotecEnalapril MaleateValeant Pharmaceuticals North America LLCNDACurrent
0187-0141VasotecEnalapril MaleateValeant Pharmaceuticals North America LLCNDACurrent
0187-0141VasotecEnalapril MaleateBausch Health US LLCNDACurrent
0187-0141VasotecEnalapril MaleateBausch Health US LLCNDACurrent
0187-0142VasotecEnalapril MaleateValeant Pharmaceuticals North America LLCNDACurrent
0187-0142VasotecEnalapril MaleateBausch Health US LLCNDACurrent
0187-0142VasotecEnalapril MaleateBausch Health US LLCNDACurrent
0187-0143VasotecEnalapril MaleateValeant Pharmaceuticals North America LLCNDACurrent
0187-0143VasotecEnalapril MaleateBausch Health US LLCNDACurrent
0187-0143VasotecEnalapril MaleateBausch Health US LLCNDACurrent
50090-5292Enalapril MaleateEnalapril MaleateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-5292Enalapril MaleateEnalapril MaleateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-5292Enalapril MaleateEnalapril MaleateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
60760-392Enalapril MaleateEnalapril MaleateSt. Mary's Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
60760-777Enalapril MaleateEnalapril MaleateSt. Mary's Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
61919-813ENALAPRIL MALEATEENALAPRIL MALEATEDIRECT RXNDA AUTHORIZED GENERICCurrent
61919-813ENALAPRIL MALEATEENALAPRIL MALEATEDIRECT RXNDA AUTHORIZED GENERICCurrent
61919-813ENALAPRIL MALEATEENALAPRIL MALEATEDIRECT RXNDA AUTHORIZED GENERICCurrent
68071-3067Enalapril MaleateEnalapril MaleateNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-3067Enalapril MaleateEnalapril MaleateNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-3067Enalapril MaleateEnalapril MaleateNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-3173Enalapril MaleateEnalapril MaleateNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-3173Enalapril MaleateEnalapril MaleateNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-3173Enalapril MaleateEnalapril MaleateNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-3245Enalapril MaleateEnalapril MaleateNuCare Pharmaceuticals, INDA AUTHORIZED Current
68071-3245Enalapril MaleateEnalapril MaleateNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-3245Enalapril MaleateEnalapril MaleateNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-3303Enalapril MaleateEnalapril MaleateNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-3303Enalapril MaleateEnalapril MaleateNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-3303Enalapril MaleateEnalapril MaleateNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68682-710Enalapril MaleateEnalapril MaleateOCEANSIDE PHARMACEUTICALSNDA AUTHORIZED GENERICCurrent
68682-710Enalapril MaleateEnalapril MaleateOCEANSIDE PHARMACEUTICALSNDA AUTHORIZED GENERICCurrent
68682-711Enalapril MaleateEnalapril MaleateOCEANSIDE PHARMACEUTICALSNDA AUTHORIZED GENERICCurrent
68682-711Enalapril MaleateEnalapril MaleateOCEANSIDE PHARMACEUTICALSNDA AUTHORIZED GENERICCurrent
68682-712Enalapril MaleateEnalapril MaleateOCEANSIDE PHARMACEUTICALSNDA AUTHORIZED GENERICCurrent
68682-712Enalapril MaleateEnalapril MaleateOCEANSIDE PHARMACEUTICALSNDA AUTHORIZED GENERICCurrent
68682-713Enalapril MaleateEnalapril MaleateOCEANSIDE PHARMACEUTICALSNDA AUTHORIZED GENERICCurrent
68682-713Enalapril MaleateEnalapril MaleateOCEANSIDE PHARMACEUTICALSNDA AUTHORIZED GENERICCurrent
68788-7244Enalapril MaleateEnalapril MaleatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7244Enalapril MaleateEnalapril MaleatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7244Enalapril MaleateEnalapril MaleatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7244Enalapril MaleateEnalapril MaleatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7275Enalapril MaleateEnalapril MaleatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7275Enalapril MaleateEnalapril MaleatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7275Enalapril MaleateEnalapril MaleatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7309Enalapril MaleateEnalapril MaleatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7309Enalapril MaleateEnalapril MaleatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7309Enalapril MaleateEnalapril MaleatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7309Enalapril MaleateEnalapril MaleatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
70518-0520Enalapril MaleateEnalapril MaleateREMEDYREPACK INC.NDA AUTHORIZED Current
70518-0520Enalapril MaleateEnalapril MaleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-0520Enalapril MaleateEnalapril MaleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-0624VasotecEnalapril MaleateREMEDYREPACK INC.NDACurrent
70518-0624VasotecEnalapril MaleateREMEDYREPACK INC.NDACurrent
70518-1190Enalapril MaleateEnalapril MaleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1190Enalapril MaleateEnalapril MaleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1190Enalapril MaleateEnalapril MaleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1190Enalapril MaleateEnalapril MaleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1372VasotecEnalapril MaleateREMEDYREPACK INC.NDACurrent
70518-1372VasotecEnalapril MaleateREMEDYREPACK INC.NDACurrent
70518-1626VasotecEnalapril MaleateREMEDYREPACK INC.NDACurrent
70518-1626VasotecEnalapril MaleateREMEDYREPACK INC.NDACurrent
70518-1821Enalapril MaleateEnalapril MaleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1958VasotecEnalapril MaleateREMEDYREPACK INC.NDACurrent
70518-2348Enalapril MaleateEnalapril MaleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2348Enalapril MaleateEnalapril MaleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2348Enalapril MaleateEnalapril MaleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
71205-075Enalapril MaleateEnalapril MaleateProficient Rx LPNDA AUTHORIZED GENERICCurrent
71205-075Enalapril MaleateEnalapril MaleateProficient Rx LPNDA AUTHORIZED GENERICCurrent
71335-0055Enalapril MaleateEnalapril MaleateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0055Enalapril MaleateEnalapril MaleateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0055Enalapril MaleateEnalapril MaleateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0055Enalapril MaleateEnalapril MaleateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0055Enalapril MaleateEnalapril MaleateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0305Enalapril MaleateEnalapril MaleateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0305Enalapril MaleateEnalapril MaleateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0305Enalapril MaleateEnalapril MaleateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0305Enalapril MaleateEnalapril MaleateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55354SUPPL2018-08-29
49048SUPPL2017-07-25
1193SUPPL2015-08-27
33685SUPPL2015-08-26
33684SUPPL2015-01-09
1192SUPPL2014-12-30
16167SUPPL2012-09-17
11409SUPPL2012-09-14
1191SUPPL2012-02-23
33683SUPPL2012-02-22
40852SUPPL2011-02-15
20186SUPPL2011-02-15
40849SUPPL2011-01-04
20185SUPPL2011-01-04
20184SUPPL2011-01-04
11408SUPPL2010-05-18
1190SUPPL2008-09-29
20178SUPPL2007-11-19
20177SUPPL2007-11-19
20176SUPPL2007-11-19
1189SUPPL2007-11-08
40847SUPPL2007-09-14
20183SUPPL2007-09-14
20179SUPPL2007-09-14
40846SUPPL2007-07-20
40845SUPPL2007-07-20
20182SUPPL2007-07-20
40848SUPPL2007-07-06
40844SUPPL2007-07-06
20189SUPPL2007-07-06
20188SUPPL2007-07-06
20181SUPPL2007-07-06
20180SUPPL2007-07-06
40851SUPPL2007-06-12
40850SUPPL2007-06-12
20187SUPPL2007-06-12
40853SUPPL2007-04-09
20190SUPPL2007-04-09
40856SUPPL2006-10-26
40843SUPPL2006-10-26
40842SUPPL2006-10-26
40841SUPPL2006-10-26
20194SUPPL2006-10-25
20193SUPPL2006-10-25
44027ORIG2006-06-09
20175ORIG2005-04-27
16166SUPPL2002-08-30
33681SUPPL2001-11-27
20192SUPPL2001-11-27
1188SUPPL2001-11-27
20191SUPPL2001-06-22
40855SUPPL2001-02-13
33682SUPPL2001-02-13
16165SUPPL2001-02-13
40854SUPPL1997-06-11