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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075483-001ENALAPRIL MALEATEENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22
A075483-002ENALAPRIL MALEATEENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22
A075483-003ENALAPRIL MALEATEENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22
A075483-004ENALAPRIL MALEATEENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A075483-001AB
A075483-002AB
A075483-003AB
A075483-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-001ENALAPRIL MALEATE2.5MGTABLET / ORALAB2000-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-002ENALAPRIL MALEATE5MGTABLET / ORALAB2000-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-003ENALAPRIL MALEATE10MGTABLET / ORALAB2000-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-004ENALAPRIL MALEATE20MGTABLET / ORALAB2000-08-22d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075483-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075483-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075483-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075483-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075483-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075483-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075483-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075483-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075483-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075483-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075483-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075483-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075483-004AB1d8e5a09893c0…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ENALAPRIL MALEATEENALAPRIL MALEATEAmici Pharma, Inca88902bd-742f-4ea6-b625-cc9df1709efc2025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075483
application number: ANDA075483

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 168 matching rows.

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