FDA.reportPublic FDA data

Application 080951

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VITAMIN DERGOCALCIFEROLCAPSULE;ORAL50,000 IUNoNo

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
A080951-001VITAMIN DERGOCALCIFEROL50,000 IUCAPSULE / 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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A080951-001VITAMIN D50,000 IUCAPSULE / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080951-001VITAMIN D50,000 IUCAPSULE / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080951-001VITAMIN D50,000 IUCAPSULE / 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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ERGOCALCIFEROLERGOCALCIFEROLTorrent Pharmaceuticals Limited4ae38744-020d-4c37-a6f1-88f55c2f10472026-09-04Warnings, Adverse reactionsName fallback
generic name: ERGOCALCIFEROL
VITAMIN DERGOCALCIFEROLREMEDYREPACK INC.3fe92511-0b4a-43f4-9c89-c8599469c1e22026-07-14Warnings, Adverse reactionsName fallback
brand name: VITAMIN D
generic name: ERGOCALCIFEROL
ErgocalciferolERGOCALCIFEROLREMEDYREPACK INC.a80436e0-b507-4e7b-9a60-a9d5ddc4a0452026-06-24Warnings, Adverse reactionsName fallback
generic name: ERGOCALCIFEROL
VITAMIN DERGOCALCIFEROLAphena Pharma Solutions - Tennessee, LLC3c0f4142-cc1f-43de-8677-ee06b6f4fc102026-06-17Warnings, Adverse reactionsName fallback
brand name: VITAMIN D
generic name: ERGOCALCIFEROL
ErgocalciferolERGOCALCIFEROLBryant Ranch Prepack0d230fd8-2ea7-4dd6-a506-5f7804e539fc2026-05-20Warnings, Adverse reactionsName fallback
generic name: ERGOCALCIFEROL
ErgocalciferolERGOCALCIFEROLBryant Ranch Prepackc4793165-6647-4dba-b100-3986739cd01e2026-05-19Warnings, Adverse reactionsName fallback
generic name: ERGOCALCIFEROL
ErgocalciferolERGOCALCIFEROLBryant Ranch Prepack39b72d09-cedc-4130-89a3-1ea03f58ba042026-05-14Warnings, Adverse reactionsName fallback
generic name: ERGOCALCIFEROL
ErgocalciferolERGOCALCIFEROLSt. Mary's Medical Park Pharmacy5f4ef344-7880-3375-e053-2a91aa0a47b82026-05-05Warnings, Adverse reactionsName fallback
generic name: ERGOCALCIFEROL
ErgocalciferolERGOCALCIFEROLPD-Rx Pharmaceuticals, Inc.2475e731-0072-4787-8a40-09137883c6252026-05-05Warnings, Adverse reactionsName fallback
generic name: ERGOCALCIFEROL
ErgocalciferolERGOCALCIFEROLNuCare Pharmaceuticals, Inc.492452d6-2b32-39c0-e054-00144ff8d46c2026-04-30Warnings, Adverse reactionsName fallback
generic name: ERGOCALCIFEROL
ErgocalciferolERGOCALCIFEROLPreferred Pharmaceuticals Inc.1cd4afc6-ef90-4e7b-9f11-2bfbd137524c2026-03-17Warnings, Adverse reactionsName fallback
generic name: ERGOCALCIFEROL
VITAMIN DERGOCALCIFEROLAvPAKa2b82923-f0dd-641f-e053-2995a90a7c4a2026-01-08Warnings, Adverse reactionsName fallback
brand name: VITAMIN D
generic name: ERGOCALCIFEROL
VITAMIN DERGOCALCIFEROLNorthwind Health Company, LLCf3402462-5d86-b4c9-e053-2a95a90aaab02026-01-01Warnings, Adverse reactionsName fallback
brand name: VITAMIN D
generic name: ERGOCALCIFEROL
ErgocalciferolERGOCALCIFEROLAvKAREf55eafcd-dfd9-fdae-c39f-ae07aa852ce12025-12-03Warnings, Adverse reactionsName fallback
generic name: ERGOCALCIFEROL
ErgocalciferolERGOCALCIFEROLBionpharma Inc.2a8d73d6-9991-401b-ab8b-81f22e5a06952025-12-01Warnings, Adverse reactionsName fallback
generic name: ERGOCALCIFEROL
VITAMIN DERGOCALCIFEROLPreferred Pharmaceuticals, Inc.ba2076ef-1650-45e1-b092-a4c449dd62102025-10-07Warnings, Adverse reactionsName fallback
brand name: VITAMIN D
generic name: ERGOCALCIFEROL
VITAMIN DERGOCALCIFEROLGolden State Medical Supply, Inc.26aba724-8990-def9-e063-6394a90a991d2025-04-15Warnings, Adverse reactionsName fallback
brand name: VITAMIN D
generic name: ERGOCALCIFEROL
VITAMIN DERGOCALCIFEROLPD-Rx Pharmaceuticals, Inc.7e9b75e3-eb7c-4227-b953-166ac6897e542025-04-01Warnings, Adverse reactionsName fallback
brand name: VITAMIN D
generic name: ERGOCALCIFEROL
Vitamin DVITAMIN DDirectRX84647b52-3c4c-31bb-e053-2991aa0a8a7e2025-03-19Warnings, Adverse reactionsName fallback
brand name: Vitamin D
VITAMIN DERGOCALCIFEROLStrides Pharma Science Limited2c4c0a36-12cf-444d-9d57-de983eef4d362025-03-10Warnings, Adverse reactionsName fallback
brand name: VITAMIN D
generic name: ERGOCALCIFEROL

Reported adverse events (FAERS/openFDA)#

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