Home Applications 018312 Application 018312
Type NDA
Sponsor ORGANON USA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CALDEROL CALCIFEDIOL CAPSULE;ORAL 0.02MG No No 002 CALDEROL CALCIFEDIOL CAPSULE;ORAL 0.05MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018312-001 CALDEROL CALCIFEDIOL 0.02MG CAPSULE / ORAL Approved before 1982 N018312-002 CALDEROL CALCIFEDIOL 0.05MG CAPSULE / ORAL Approved 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 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018312-001 CALDEROL 0.02MG CAPSULE / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N018312-002 CALDEROL 0.05MG CAPSULE / ORAL Approved before 1982 782e0a99824c…
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 · 1 matching rows.