FDA.reportPublic FDA data

Application 011073

Type
NDA
Sponsor
MEDPOINTE PHARM HLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003WAMPOCAPNIACINCAPSULE;ORAL500MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N011073-003WAMPOCAPNIACIN500MGCAPSULE / ORALApproved before 1982

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N011073-003WAMPOCAP500MGCAPSULE / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N011073-003WAMPOCAP500MGCAPSULE / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N011073-003WAMPOCAP500MGCAPSULE / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N011073-003WAMPOCAP500MGCAPSULE / ORALApproved before 1982a50c72e98297…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NiacinNIACINGolden State Medical Supply, Inc.8eff9205-84ac-e69d-e053-2995a90aad4b2026-04-15Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINAvPAKdd60fe81-3d54-4a29-9502-601be89c575e2026-02-25Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINQUAGEN PHARMACEUTICALS LLC249e27ac-e1e7-42dc-84f6-cd32fd1d9dee2025-12-25Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINRedmont Pharmaceuticals, LLCf51f7e6d-b132-48d8-8bb1-54203472f0d82025-12-17Warnings, Adverse reactionsName fallback
generic name: NIACIN
NIACINNIACINChartwell RX, LLC568c3a99-b6e8-48b4-bb68-867bbcefa0272025-12-08Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINLannett Company, Inc.d7b66e13-00ed-48a9-a54a-8e474cc31d542025-11-10Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINAmneal Pharmaceuticals LLC7250313b-b2ef-4736-bd25-2f29c2ac0eb92025-10-03Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINMacleods Pharmaceuticals Limited52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e2025-01-10Warnings, Adverse reactionsName fallback
generic name: NIACIN
NIACINNIACINSun Pharmaceutical Industries, Inc.8e290f96-e8c6-47fd-863f-1c9480f28d9b2023-11-24Warnings, Adverse reactionsName fallback
generic name: NIACIN
NIACINNIACINLupin Pharmaceuticals, Inc.92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b92023-10-06Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINAurobindo Pharma Limited43233a21-3f90-4c69-bbeb-f50d5f2d35ae2023-02-14Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacorNIACINAvondale Pharmaceuticals, LLCbf287412-160b-403f-8eb4-57f29a4759022021-12-23Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINEmerald Therapeutics, LLC5fceeb58-e54d-43c1-8abb-33feea69d6632021-04-07Warnings, Adverse reactionsName fallback
generic name: NIACIN

Reported adverse events (FAERS/openFDA)#

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