Application 091433

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXERCALCIFEROL	DOXERCALCIFEROL	CAPSULE;ORAL	0.5MCG	No	No
002	DOXERCALCIFEROL	DOXERCALCIFEROL	CAPSULE;ORAL	1MCG	No	No
003	DOXERCALCIFEROL	DOXERCALCIFEROL	CAPSULE;ORAL	2.5MCG	No	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	Approval date
A091433-001	DOXERCALCIFEROL	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	2011-09-23
A091433-002	DOXERCALCIFEROL	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	2014-01-14
A091433-003	DOXERCALCIFEROL	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	2014-01-14

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091433-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	2011-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091433-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	2014-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091433-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	2014-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091433-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	2011-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091433-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	2014-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091433-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	2014-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091433-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	2011-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091433-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	2014-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091433-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	2014-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091433-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	2011-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091433-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	2014-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091433-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	2014-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091433-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	2011-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091433-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	2014-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091433-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	2014-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091433-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	2011-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091433-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	2014-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091433-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	2014-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091433-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	2011-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091433-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	2014-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091433-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	2014-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091433-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	2011-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091433-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	2014-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091433-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	2014-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091433-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	2011-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091433-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	2014-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091433-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	2014-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091433-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	2011-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091433-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	2014-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091433-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	2014-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091433-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	2011-09-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091433-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	2014-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091433-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	2014-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091433-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	2011-09-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091433-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	2014-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091433-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	2014-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091433-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	2011-09-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091433-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	2014-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091433-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	2014-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091433-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	2011-09-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A091433-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091433-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091433-003	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A091433-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091433-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091433-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091433-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091433-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091433-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091433-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091433-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091433-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091433-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091433-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091433-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091433-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091433-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091433-003	AB	1	`ea99ee380514…`

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 brand name: Doxercalciferol 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 brand name: Doxercalciferol generic name: DOXERCALCIFEROL
Doxercalciferol	DOXERCALCIFEROL	Eugia US LLC	3376536b-043d-478a-b129-7ce11ec94e3e	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: Doxercalciferol generic name: DOXERCALCIFEROL
DOXERCALCIFEROL	DOXERCALCIFEROL	Dr.Reddy's Laboratories Inc	f472b60a-e6f5-1a87-3eff-539d6287d285	2024-12-20	Warnings, Adverse reactions	Name fallback brand name: DOXERCALCIFEROL generic name: DOXERCALCIFEROL
Doxercalciferol	DOXERCALCIFEROL	Gland Pharma Limited	f0d79a1b-c7fb-4521-941a-5d6c2fd50170	2024-11-06	Warnings, Adverse reactions	Name fallback brand name: Doxercalciferol generic name: DOXERCALCIFEROL
Doxercalciferol	DOXERCALCIFEROL	Chartwell RX, LLC	356fb38a-791c-48f0-9312-6203ae57d80c	2024-10-10	Warnings, Adverse reactions	Name fallback brand name: Doxercalciferol generic name: DOXERCALCIFEROL
Doxercalciferol	DOXERCALCIFEROL	Alembic Pharmaceuticals Inc.	7d07fa4f-f2a2-4c2b-86bf-c0a4691c1a0a	2024-07-10	Warnings, Adverse reactions	Name fallback brand name: Doxercalciferol generic name: DOXERCALCIFEROL
Doxercalciferol	DOXERCALCIFEROL	Meitheal Pharmaceuticals Inc.	81a30e4b-be74-41d6-8277-b4f0ea5c15bc	2024-07-01	Warnings, Adverse reactions	Name fallback brand name: Doxercalciferol generic name: DOXERCALCIFEROL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0338	Doxercalciferol	Doxercalciferol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0338	Doxercalciferol	Doxercalciferol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0338	Doxercalciferol	Doxercalciferol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0338	Doxercalciferol	Doxercalciferol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0338	Doxercalciferol	Doxercalciferol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0339	Doxercalciferol	Doxercalciferol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0339	Doxercalciferol	Doxercalciferol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0339	Doxercalciferol	Doxercalciferol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0339	Doxercalciferol	Doxercalciferol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0339	Doxercalciferol	Doxercalciferol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0388	Doxercalciferol	Doxercalciferol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0388	Doxercalciferol	Doxercalciferol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0388	Doxercalciferol	Doxercalciferol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0388	Doxercalciferol	Doxercalciferol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0388	Doxercalciferol	Doxercalciferol	West-Ward Pharmaceuticals Corp.	ANDA	Current
68084-872	Doxercalciferol	Doxercalciferol	American Health Packaging	ANDA	Current
68084-872	Doxercalciferol	Doxercalciferol	American Health Packaging	ANDA	Current
68084-872	Doxercalciferol	Doxercalciferol	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9339	ORIG	2011-11-07