FDA.reportPublic FDA data

Application 090697

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAMIPRILRAMIPRILTABLET;ORAL1.25MGNoNo
002RAMIPRILRAMIPRILTABLET;ORAL2.5MGNoNo
003RAMIPRILRAMIPRILTABLET;ORAL5MGNoNo
004RAMIPRILRAMIPRILTABLET;ORAL10MGNoNo

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
A090697-001RAMIPRILRAMIPRIL1.25MGTABLET / ORAL2009-09-24
A090697-002RAMIPRILRAMIPRIL2.5MGTABLET / ORAL2009-09-24
A090697-003RAMIPRILRAMIPRIL5MGTABLET / ORAL2009-09-24
A090697-004RAMIPRILRAMIPRIL10MGTABLET / ORAL2009-09-24

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 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-246a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-246a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-246a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-241c564ffb4f44…
2024-02-18 07:12 UTC2024-02A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-241c564ffb4f44…
2024-02-18 07:12 UTC2024-02A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-241c564ffb4f44…
2024-02-18 07:12 UTC2024-02A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-24ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-24ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-24ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-24a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-24a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-24a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-249b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-249b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-249b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-24a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-24a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-24a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-243f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-243f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-243f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-24053a50430f4f…
2023-05-13 08:27 UTC2023-05A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-24053a50430f4f…
2023-05-13 08:27 UTC2023-05A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-24053a50430f4f…
2023-05-13 08:27 UTC2023-05A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-243bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-243bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-243bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-243a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-243a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-243a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-243a93d1ddd44b…

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RamiprilRAMIPRILBluePoint Laboratories45707435-4fc8-457e-9ff2-02d7be9b4a6e2026-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILLupin Pharmaceuticals, Inc.a8cdec12-81d1-4ef4-82c0-d05d93c37a072026-08-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILRising Pharma Holdings, Inc.d5c58fb5-b415-4567-9790-55631705c5cd2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILBryant Ranch Prepack245d3580-77c6-4c0f-b324-c8514b792c592026-08-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILBryant Ranch Prepack3806abdc-6aec-4252-bd79-e2c115b849aa2026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILZydus Pharmaceuticals USA Inc.055bb582-67cd-425a-8823-d543c14305ce2026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILBryant Ranch Prepackef05b44e-4bf7-4afa-a5f6-06efa0d0abc32026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILBryant Ranch Prepack8be00433-3113-437e-8ab6-721af4d791852026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILBryant Ranch Prepackd270b634-0d6d-4614-b223-a2af1e238c2f2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILHikma Pharmaceuticals USA Inc.7e9e84f7-ff47-463d-bf47-7a9745960aae2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILNuCare Pharmaceuticals, Inc.4bd2d586-6851-4a40-e063-6394a90a0cab2026-02-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILA-S Medication Solutionse8d9a115-71a7-4580-abbd-865e98b5d3f62026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILA-S Medication Solutionsd856fb57-f1a0-49e6-bb2d-b4924af485152026-02-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILA-S Medication Solutionsa3786664-a1b5-4914-99d6-79fb0e330e982026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILChartwell RX, LLC.b7e49f05-6d4f-465a-b0d7-f704466a2e522026-01-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILNorthwind Health Company, LLCf2b87655-93c3-16a5-e053-2a95a90a593c2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILNorthwind Health Company, LLCab3124b7-deed-8e04-e053-2a95a90a3b852026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILNorthwind Health Company, LLCf2f325b8-f33d-3b93-e053-2995a90aa6602026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILNorthwind Health Company, LLCf7e61b5b-fb5b-ba15-e053-6394a90adc3c2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILNorthwind Health Company, LLCab09a67e-18fe-c860-e053-2a95a90a4d032026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65841-699RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-699RamiprilRamiprilZydus Lifesciences LimitedANDACurrent
65841-699RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-699RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-700RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-700RamiprilRamiprilZydus Lifesciences LimitedANDACurrent
65841-700RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-700RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-701RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-701RamiprilRamiprilZydus Lifesciences LimitedANDACurrent
65841-701RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-701RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-702RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-702RamiprilRamiprilZydus Lifesciences LimitedANDACurrent
65841-702RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-702RamiprilRamiprilCadila Healthcare LimitedANDACurrent
68382-374RamiprilRamiprilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-374RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-374RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-375RamiprilRamiprilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-375RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-375RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-376RamiprilRamiprilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-376RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-376RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-377RamiprilRamiprilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-377RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-377RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent