FDA.reportPublic FDA data

Application 075583

Type
ANDA
Sponsor
APOTHECON

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 44.

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
A075583-001ENALAPRIL MALEATEENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-22
A075583-002ENALAPRIL MALEATEENALAPRIL MALEATE5MGTABLET / ORAL2000-08-22
A075583-003ENALAPRIL MALEATEENALAPRIL MALEATE10MGTABLET / ORAL2000-08-22
A075583-004ENALAPRIL MALEATEENALAPRIL MALEATE20MGTABLET / ORAL2000-08-22

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 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075583-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075583-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075583-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075583-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075583-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075583-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075583-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075583-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075583-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A075583-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A075583-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A075583-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075583-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075583-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075583-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075583-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075583-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075583-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075583-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075583-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075583-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075583-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075583-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075583-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075583-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075583-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075583-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075583-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075583-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075583-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075583-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075583-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075583-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075583-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075583-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075583-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075583-001ENALAPRIL MALEATE2.5MGTABLET / ORAL2000-08-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075583-002ENALAPRIL MALEATE5MGTABLET / ORAL2000-08-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075583-003ENALAPRIL MALEATE10MGTABLET / ORAL2000-08-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075583-004ENALAPRIL MALEATE20MGTABLET / ORAL2000-08-224b0b4de00fa7…

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 4 · 65 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.3fbc6cce-7ad5-49d5-9705-5f66ef92d5442026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Enalapril Maleate
generic name: ENALAPRIL MALEATE
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.5118eb9f-1466-4318-b17e-cf5898edbeef2026-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Enalapril Maleate
generic name: ENALAPRIL MALEATE
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.a5c6e64c-a3ed-44f2-83e7-f4b62b6cd6222026-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Enalapril Maleate
generic name: ENALAPRIL MALEATE
Enalapril maleateENALAPRIL MALEATEREMEDYREPACK INC.7077d32e-4b06-4d48-ba0c-6db2f8ebe08c2026-08-28Warnings, Adverse reactionsName fallback
brand name: Enalapril maleate
generic name: ENALAPRIL MALEATE
Enalapril MaleateENALAPRIL MALEATECoupler LLC59f44ba0-a323-493f-e063-6394a90a1c3c2026-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Enalapril Maleate
generic name: ENALAPRIL MALEATE
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.e47afc0d-afc4-4972-a28a-5d3c640390ab2026-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Enalapril Maleate
generic name: ENALAPRIL MALEATE
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepack7fdc2d8a-9b5d-43c4-b32f-6f2505aee33c2026-08-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Enalapril Maleate
generic name: ENALAPRIL MALEATE
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackb4b7b936-4a62-4991-8d3c-03bb37f044c12026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Enalapril Maleate
generic name: ENALAPRIL MALEATE
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackbdb34c96-1532-4ce5-93a7-3cc90904c9102026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Enalapril Maleate
generic name: ENALAPRIL MALEATE
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.1b464099-491d-473b-836e-9d86b2b1eeec2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Enalapril Maleate
generic name: ENALAPRIL MALEATE
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackfb3c7066-76cb-4e8e-b98b-bcb41a3631df2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Enalapril Maleate
generic name: ENALAPRIL MALEATE
Enalapril MaleateENALAPRIL MALEATEGolden State Medical Supply, Inc.0a12343f-5733-40cc-93b4-a02f5147fb912026-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Enalapril Maleate
generic name: ENALAPRIL MALEATE
ENALAPRIL MALEATEENALAPRIL MALEATEBryant Ranch Prepackfa93d8e6-2ed2-4a3c-bf6d-33bd0a374efa2026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ENALAPRIL MALEATE
generic name: ENALAPRIL MALEATE
Enalapril MaleateENALAPRIL MALEATEGolden State Medical Supply, Inc.074fe718-88d8-365c-e063-6394a90a299d2026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Enalapril Maleate
generic name: ENALAPRIL MALEATE
ENALAPRIL MALEATEENALAPRIL MALEATEPreferred Pharmaceuticals Inc.b31372f7-cda3-4ead-a481-4cde62e843fd2026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ENALAPRIL MALEATE
generic name: ENALAPRIL MALEATE
Enalapril MaleateENALAPRIL MALEATESun Pharmaceutical Industries, Inc.f103b9f9-e081-419d-a2d8-b86acda834dd2026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Enalapril Maleate
generic name: ENALAPRIL MALEATE
ENALAPRIL MALEATEENALAPRIL MALEATEPreferred Pharmaceuticals Inc.eee8633b-9d9e-453d-8c6b-8b13c94d2f582026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ENALAPRIL MALEATE
generic name: ENALAPRIL MALEATE
ENALAPRIL MALEATEENALAPRIL MALEATEScieGen Pharmaceuticals, Inc.63187a94-9ac7-4320-ac70-0631e08c2b8d2026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ENALAPRIL MALEATE
generic name: ENALAPRIL MALEATE
Enalapril MaleateENALAPRIL MALEATESt. Mary's Medical Park Pharmacyed266486-e4a5-9dd1-e053-2a95a90a80d32026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Enalapril Maleate
generic name: ENALAPRIL MALEATE
ENALAPRIL MALEATEENALAPRIL MALEATEBryant Ranch Prepackc1e4cd79-ece5-432c-bd3a-ed4633ccec702026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ENALAPRIL MALEATE
generic name: ENALAPRIL MALEATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8727ORIG2004-06-03
30946ORIG2000-08-22