FDA.reportPublic FDA data

Application 018917

Type
NDA
Sponsor
PROMIUS PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SECTRALACEBUTOLOL HYDROCHLORIDECAPSULE;ORALEQ 200MG BASEYesNo
003SECTRALACEBUTOLOL HYDROCHLORIDECAPSULE;ORALEQ 400MG BASEYesNo

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

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
N018917-001SECTRALACEBUTOLOL HYDROCHLORIDEEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1984-12-28
N018917-003SECTRALACEBUTOLOL HYDROCHLORIDEEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1984-12-28

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 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N018917-001SECTRALEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1984-12-28e64feba35796…
2022-09-29 23:25 UTC2022-09N018917-003SECTRALEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1984-12-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018917-001SECTRALEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1984-12-28cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018917-003SECTRALEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1984-12-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018917-001SECTRALEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1984-12-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018917-003SECTRALEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1984-12-28a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acebutolol HydrochlorideACEBUTOLOL HYDROCHLORIDEAvKAREfa40a564-a579-15c1-e053-6294a90ad8e92026-01-13Warnings, Adverse reactionsName fallback
generic name: ACEBUTOLOL HYDROCHLORIDE
Acebutolol HydrochlorideACEBUTOLOL HYDROCHLORIDEGolden State Medical Supply, Inc.f037a079-fde6-3588-e053-2995a90a66212025-12-17Warnings, Adverse reactionsName fallback
generic name: ACEBUTOLOL HYDROCHLORIDE
Acebutolol HydrochlorideACEBUTOLOL HYDROCHLORIDEANI Pharmaceuticals, Inc.48bded12-09c7-47f2-b162-ec970a77f2d82025-11-07Warnings, Adverse reactionsName fallback
generic name: ACEBUTOLOL HYDROCHLORIDE
Acebutolol HydrochlorideACEBUTOLOL HYDROCHLORIDEAvPAKff68a002-d46d-4f9f-0705-427844ea36552025-09-18Warnings, Adverse reactionsName fallback
generic name: ACEBUTOLOL HYDROCHLORIDE
Acebutolol HydrochlorideACEBUTOLOL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCfe2cd5c0-ee16-4bcb-ad92-3755881dbe792024-12-11Warnings, Adverse reactionsName fallback
generic name: ACEBUTOLOL HYDROCHLORIDE
Acebutolol HydrochlorideACEBUTOLOL HYDROCHLORIDEAmneal Pharmaceuticals LLC28f8c26c-a1e1-4485-a45f-05c82f7a34b52024-10-23Warnings, Adverse reactionsName fallback
generic name: ACEBUTOLOL HYDROCHLORIDE

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67857-700SECTRALacebutolol hydrochloridePromius Pharma, LLCNDACurrent
67857-701SECTRALacebutolol hydrochloridePromius Pharma, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11360SUPPL2014-03-17
16092SUPPL2011-03-07
33645SUPPL2007-09-11
16091SUPPL2007-09-11