Application 021027

Type: NDA
Sponsor: SANOFI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HECTOROL	DOXERCALCIFEROL	INJECTABLE;INJECTION	4MCG/2ML (2MCG/ML)	Yes	Yes
002	HECTOROL	DOXERCALCIFEROL	INJECTABLE;INJECTION	2MCG/ML (2MCG/ML)	Yes	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
N021027-001	HECTOROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION		RLD	2000-04-06
N021027-002	HECTOROL	DOXERCALCIFEROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION		RLD	2000-04-06

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	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION		RLD	2000-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION		RLD	2000-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021027-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021027-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021027-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021027-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021027-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021027-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021027-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021027-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021027-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021027-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021027-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021027-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021027-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021027-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021027-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021027-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021027-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021027-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021027-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021027-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021027-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021027-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021027-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021027-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021027-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021027-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021027-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021027-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021027-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021027-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021027-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021027-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021027-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021027-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021027-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021027-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021027-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021027-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021027-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021027-002	AP	1	`87673890dc5c…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxercalciferol	DOXERCALCIFEROL	REMEDYREPACK INC.	943a3f95-842c-455f-9050-3d1c3971c6f8	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: DOXERCALCIFEROL
Doxercalciferol	DOXERCALCIFEROL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	2ed2f592-27a7-4c10-a18a-21a3f221d3b1	2026-02-25	Warnings, Adverse reactions	Name fallback generic name: DOXERCALCIFEROL
Doxercalciferol	DOXERCALCIFEROL	Eugia US LLC	3376536b-043d-478a-b129-7ce11ec94e3e	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: DOXERCALCIFEROL
DOXERCALCIFEROL	DOXERCALCIFEROL	Dr.Reddy's Laboratories Inc	f472b60a-e6f5-1a87-3eff-539d6287d285	2024-12-20	Warnings, Adverse reactions	Name fallback generic name: DOXERCALCIFEROL
Doxercalciferol	DOXERCALCIFEROL	Gland Pharma Limited	f0d79a1b-c7fb-4521-941a-5d6c2fd50170	2024-11-06	Warnings, Adverse reactions	Name fallback generic name: DOXERCALCIFEROL
Doxercalciferol	DOXERCALCIFEROL	Chartwell RX, LLC	356fb38a-791c-48f0-9312-6203ae57d80c	2024-10-10	Warnings, Adverse reactions	Name fallback generic name: DOXERCALCIFEROL
Doxercalciferol	DOXERCALCIFEROL	Alembic Pharmaceuticals Inc.	7d07fa4f-f2a2-4c2b-86bf-c0a4691c1a0a	2024-07-10	Warnings, Adverse reactions	Name fallback generic name: DOXERCALCIFEROL
Doxercalciferol	DOXERCALCIFEROL	Meitheal Pharmaceuticals Inc.	81a30e4b-be74-41d6-8277-b4f0ea5c15bc	2024-07-01	Warnings, Adverse reactions	Name fallback generic name: DOXERCALCIFEROL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58468-0123	Hectorol	DOXERCALCIFEROL	Genzyme Corporation	NDA	Current
58468-0123	Hectorol	DOXERCALCIFEROL	Genzyme Corporation	NDA	Current
58468-0123	Hectorol	DOXERCALCIFEROL	Genzyme Corporation	NDA	Current
58468-0123	Hectorol	DOXERCALCIFEROL	Genzyme Corporation	NDA	Current
58468-0126	Hectorol	DOXERCALCIFEROL	Genzyme Corporation	NDA	Current
58468-0126	Hectorol	DOXERCALCIFEROL	Genzyme Corporation	NDA	Current
58468-0127	Hectorol	DOXERCALCIFEROL	Genzyme Corporation	NDA	Current
58468-0127	Hectorol	DOXERCALCIFEROL	Genzyme Corporation	NDA	Current
58468-0127	Hectorol	DOXERCALCIFEROL	Genzyme Corporation	NDA	Current
58468-0127	Hectorol	DOXERCALCIFEROL	Genzyme Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72401	SUPPL	2022-10-17
72181	SUPPL	2022-09-29
56749	SUPPL	2018-12-14
56550	SUPPL	2018-11-23
26526	SUPPL	2016-06-06
14196	SUPPL	2016-06-02
21361	SUPPL	2012-05-09
35928	SUPPL	2009-01-02
4089	SUPPL	2008-12-11
14195	SUPPL	2006-07-21
4088	SUPPL	2006-07-21
35927	SUPPL	2005-06-23
26525	SUPPL	2005-06-23
4087	SUPPL	2003-12-04
35926	ORIG	2000-04-06
26524	ORIG	2000-04-06
21360	ORIG	2000-04-06