Home Applications 207174 Application 207174
Type NDA
Sponsor ACCORD HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.002MG/ML (0.002MG/ML) No No 002 PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.005MG/ML (0.005MG/ML) No No 003 PARICALCITOL PARICALCITOL SOLUTION;INTRAVENOUS 0.01MG/2ML (0.005MG/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207174-001 PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 N207174-002 PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 N207174-003 PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 126 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 2026-08-18 06:07:40 2026-07 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16729-310 Paricalcitol Paricalcitol Accord Healthcare, Inc. NDA Current 16729-310 Paricalcitol Paricalcitol Accord Healthcare, Inc. NDA Current 16729-310 Paricalcitol Paricalcitol Accord Healthcare, Inc. NDA Current 16729-311 Paricalcitol Paricalcitol Accord Healthcare, Inc. NDA Current 16729-311 Paricalcitol Paricalcitol Accord Healthcare, Inc. NDA Current 16729-311 Paricalcitol Paricalcitol Accord Healthcare, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 60589 SUPPL 2019-10-18 60586 SUPPL 2019-10-18 46033 ORIG 2016-12-06 46032 ORIG 2016-12-06 19961 ORIG 2016-03-04 32850 ORIG 2016-02-09