FDA.reportPublic FDA data

Application 078849

Type
ANDA
Sponsor
RANBAXY LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAMIPRILRAMIPRILCAPSULE;ORAL5MGNoNo
002RAMIPRILRAMIPRILCAPSULE;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078849-001RAMIPRILRAMIPRIL5MGCAPSULE / ORAL2009-03-06
A078849-002RAMIPRILRAMIPRIL10MGCAPSULE / ORAL2009-03-06

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078849-001RAMIPRIL5MGCAPSULE / ORAL2009-03-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A078849-002RAMIPRIL10MGCAPSULE / ORAL2009-03-06782e0a99824c…

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 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RamiprilRAMIPRILBryant Ranch Prepack3806abdc-6aec-4252-bd79-e2c115b849aa2026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILAurobindo Pharma Limitedd6d57158-e8f9-4c91-8317-0374e0c87d332026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILLupin Pharmaceuticals, Inc.a8cdec12-81d1-4ef4-82c0-d05d93c37a072026-06-18Boxed 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
RamiprilRAMIPRILREMEDYREPACK INC.f6c86139-b1f7-4e84-944f-94af883ce4ea2026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ramipril
generic name: RAMIPRIL
RamiprilRAMIPRILREMEDYREPACK INC.fcf42121-8e85-4eae-82b4-bc029653b4622026-04-23Boxed 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
RamiprilRAMIPRILREMEDYREPACK INC.394a49a8-81bb-43ba-8d6a-fa6fa50305872026-02-17Boxed 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