FDA.reportPublic FDA data

Application 219757

Type
NDA
Sponsor
ROSEMONT PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VOSTALLYRAMIPRILSOLUTION;ORAL1MG/MLYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219757-001VOSTALLYRAMIPRIL1MG/MLSOLUTION / ORALRLD2025-07-23

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219757-001123433382039-08-16U-4233Drug product2025-07-30

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N219757-001VOSTALLY1MG/MLSOLUTION / ORALRLD2025-07-2384e616aacf4f…
2026-08-18 06:07:402026-07N219757-001VOSTALLY1MG/MLSOLUTION / ORALRLD2025-07-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219757-001VOSTALLY1MG/MLSOLUTION / ORALRLD, RS2025-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219757-001VOSTALLY1MG/MLSOLUTION / ORALRLD, RS2025-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N219757-001VOSTALLY1MG/MLSOLUTION / ORALRLD, RS2025-07-236a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219757-001VOSTALLY1MG/MLSOLUTION / ORALRLD2025-07-23a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N219757-001123433382039-08-16U-4233Drug product2025-07-3084e616aacf4f…
2026-08-18 06:07:402026-07N219757-001123433382039-08-16U-4233Drug product2025-07-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219757-001123433382039-08-16U-4233Drug product2025-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219757-001123433382039-08-16U-4233Drug product2025-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N219757-001123433382039-08-16U-4233Drug product2025-07-306a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219757-001123433382039-08-16U-4233Drug product2025-07-30a50c72e98297…

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 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RamiprilRAMIPRILNorthwind Health Company, LLCab09a67e-18fe-c860-e053-2a95a90a4d032026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RAMIPRIL
RamiprilRAMIPRILNorthwind Health Company, LLCab324cb3-2aaa-b57f-e053-2995a90a20552026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RAMIPRIL
RamiprilRAMIPRILNorthwind Health Company, LLCfb0892da-3db7-3202-e053-6394a90ab6052026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RAMIPRIL
RamiprilRAMIPRILA-S Medication Solutions5fb23b7d-ed2b-4984-89c8-d0a509b917e12025-12-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RAMIPRIL
RamiprilRAMIPRILGSMS, Incorporated62f6aa5a-7587-4349-b61d-b2c2357499792025-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RAMIPRIL
RamiprilRAMIPRILA-S Medication Solutions1576188e-efd4-4e14-870e-fd9bd2751c452025-04-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RAMIPRIL
RamiprilRAMIPRILA-S Medication Solutionsdd3162eb-5f09-47ac-9efd-3ddeee695a252025-04-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RAMIPRIL
RamiprilRAMIPRILZydus Lifesciences Limited496b346b-ca79-4483-a950-bed9464e6a9d2024-12-04Name fallback
generic name: RAMIPRIL
RamiprilRAMIPRILA-S Medication Solutions4a91b706-c614-4472-92f2-4da5d7bdbf272024-11-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RAMIPRIL
RamiprilRAMIPRILProficient Rx LP01da05d8-e72e-4208-bf92-a5cd929f15ab2022-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RAMIPRIL
RamiprilRAMIPRILExelan Pharmaceuticals, Inc.1e1dfacf-b831-4743-a874-9a5e5ef8a1202021-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RAMIPRIL
RamiprilRAMIPRILProficient Rx LP33bdfe96-1b7a-4859-b1c9-ef94b8bb7a2a2019-11-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RAMIPRIL
RamiprilRAMIPRILProficient Rx LPafd766bc-2a42-40b5-b33f-1a8b5ce2622e2019-11-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RAMIPRIL
RamiprilRAMIPRILProficient Rx LP543914e5-c164-4fc7-8007-9fab2b13dda72019-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RAMIPRIL
RamiprilRAMIPRILProficient Rx LPd3513b8b-2d8a-456d-b942-a25ec1965b042019-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RAMIPRIL

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82935ORIG 2025-07-25
82923ORIG 2025-07-25