Application 020862

Type: NDA
Sponsor: SANOFI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HECTOROL	DOXERCALCIFEROL	CAPSULE;ORAL	2.5MCG	Yes	Yes
002	HECTOROL	DOXERCALCIFEROL	CAPSULE;ORAL	0.5MCG	Yes	No
003	HECTOROL	DOXERCALCIFEROL	CAPSULE;ORAL	1MCG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
N020862-001	HECTOROL	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	RLD	1999-06-09
N020862-002	HECTOROL	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	RLD	2004-04-23
N020862-003	HECTOROL	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	RLD	2009-07-13

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N020862-001	M-14	2028-06-11
N020862-002	M-14	2028-06-11
N020862-003	M-14	2028-06-11

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 · 123 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	N020862-001	HECTOROL	2.5MCG	CAPSULE / ORAL		RLD	1999-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020862-002	HECTOROL	0.5MCG	CAPSULE / ORAL		RLD	2004-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020862-003	HECTOROL	1MCG	CAPSULE / ORAL		RLD	2009-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020862-001	HECTOROL	2.5MCG	CAPSULE / ORAL		RLD	1999-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020862-002	HECTOROL	0.5MCG	CAPSULE / ORAL		RLD	2004-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020862-003	HECTOROL	1MCG	CAPSULE / ORAL		RLD	2009-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020862-001	HECTOROL	2.5MCG	CAPSULE / ORAL	AB	RLD, RS	1999-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020862-002	HECTOROL	0.5MCG	CAPSULE / ORAL	AB	RLD	2004-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020862-003	HECTOROL	1MCG	CAPSULE / ORAL	AB	RLD	2009-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020862-001	HECTOROL	2.5MCG	CAPSULE / ORAL	AB	RLD, RS	1999-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020862-002	HECTOROL	0.5MCG	CAPSULE / ORAL	AB	RLD	2004-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020862-003	HECTOROL	1MCG	CAPSULE / ORAL	AB	RLD	2009-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020862-001	HECTOROL	2.5MCG	CAPSULE / ORAL	AB	RLD, RS	1999-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020862-002	HECTOROL	0.5MCG	CAPSULE / ORAL	AB	RLD	2004-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020862-003	HECTOROL	1MCG	CAPSULE / ORAL	AB	RLD	2009-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020862-001	HECTOROL	2.5MCG	CAPSULE / ORAL	AB	RLD, RS	1999-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020862-002	HECTOROL	0.5MCG	CAPSULE / ORAL	AB	RLD	2004-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020862-003	HECTOROL	1MCG	CAPSULE / ORAL	AB	RLD	2009-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020862-001	HECTOROL	2.5MCG	CAPSULE / ORAL	AB	RLD, RS	1999-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020862-002	HECTOROL	0.5MCG	CAPSULE / ORAL	AB	RLD	2004-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020862-003	HECTOROL	1MCG	CAPSULE / ORAL	AB	RLD	2009-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020862-001	HECTOROL	2.5MCG	CAPSULE / ORAL	AB	RLD, RS	1999-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020862-002	HECTOROL	0.5MCG	CAPSULE / ORAL	AB	RLD	2004-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020862-003	HECTOROL	1MCG	CAPSULE / ORAL	AB	RLD	2009-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020862-001	HECTOROL	2.5MCG	CAPSULE / ORAL	AB	RLD, RS	1999-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020862-002	HECTOROL	0.5MCG	CAPSULE / ORAL	AB	RLD	2004-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020862-003	HECTOROL	1MCG	CAPSULE / ORAL	AB	RLD	2009-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020862-001	HECTOROL	2.5MCG	CAPSULE / ORAL	AB	RLD, RS	1999-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020862-002	HECTOROL	0.5MCG	CAPSULE / ORAL	AB	RLD	2004-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020862-003	HECTOROL	1MCG	CAPSULE / ORAL	AB	RLD	2009-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020862-001	HECTOROL	2.5MCG	CAPSULE / ORAL	AB	RLD, RS	1999-06-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020862-002	HECTOROL	0.5MCG	CAPSULE / ORAL	AB	RLD	2004-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020862-003	HECTOROL	1MCG	CAPSULE / ORAL	AB	RLD	2009-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020862-001	HECTOROL	2.5MCG	CAPSULE / ORAL	AB	RLD, RS	1999-06-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020862-002	HECTOROL	0.5MCG	CAPSULE / ORAL	AB	RLD	2004-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020862-003	HECTOROL	1MCG	CAPSULE / ORAL	AB	RLD	2009-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020862-001	HECTOROL	2.5MCG	CAPSULE / ORAL	AB	RLD, RS	1999-06-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020862-002	HECTOROL	0.5MCG	CAPSULE / ORAL	AB	RLD	2004-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020862-003	HECTOROL	1MCG	CAPSULE / ORAL	AB	RLD	2009-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020862-001	HECTOROL	2.5MCG	CAPSULE / ORAL	AB	RLD, RS	1999-06-09	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N020862-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020862-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020862-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020862-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020862-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020862-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020862-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020862-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020862-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020862-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020862-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020862-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020862-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020862-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020862-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020862-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020862-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020862-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020862-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020862-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020862-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020862-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020862-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020862-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020862-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020862-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020862-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020862-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020862-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020862-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020862-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020862-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020862-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020862-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020862-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020862-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020862-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020862-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020862-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020862-001	AB	1	`5d02ea3f76ae…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020862-001	M-14	2028-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020862-002	M-14	2028-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020862-003	M-14	2028-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020862-001	M-14	2028-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020862-002	M-14	2028-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020862-003	M-14	2028-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020862-001	M-14	2028-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020862-002	M-14	2028-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020862-003	M-14	2028-06-11	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020862-001	M-14	2028-06-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020862-002	M-14	2028-06-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020862-003	M-14	2028-06-11	`a50c72e98297…`

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0955-1720	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1720	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA	Current
0955-1720	Doxercalciferol	Doxercalciferol	Winthrop U.S, a business of sanofi-aventis U.S. LLC	NDA AUTHORIZED GENERIC	Current
0955-1720	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA	Current
0955-1720	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1721	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1721	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA	Current
0955-1721	Doxercalciferol	Doxercalciferol	Winthrop U.S, a business of sanofi-aventis U.S. LLC	NDA AUTHORIZED GENERIC	Current
0955-1721	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA	Current
0955-1721	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1722	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1722	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA	Current
0955-1722	Doxercalciferol	Doxercalciferol	Winthrop U.S, a business of sanofi-aventis U.S. LLC	NDA AUTHORIZED GENERIC	Current
0955-1722	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA	Current
0955-1722	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82558	SUPPL	2025-06-12
82555	SUPPL	2025-06-12
56748	SUPPL	2018-12-14
56549	SUPPL	2018-11-23
13632	SUPPL	2011-03-04
26072	SUPPL	2011-02-15
13631	SUPPL	2009-07-23
3598	SUPPL	2009-07-17
13630	SUPPL	2008-07-14
3597	SUPPL	2008-07-14
26071	SUPPL	2006-07-21
13629	SUPPL	2006-07-21
35525	SUPPL	2005-06-29
3596	SUPPL	2005-06-29
3595	SUPPL	2004-12-30
35524	SUPPL	2004-05-04
3594	SUPPL	2004-04-29
35523	ORIG	1999-06-09
26070	ORIG	1999-06-09
21026	ORIG	1999-06-09