Application 018874

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALCIJEX	CALCITRIOL	INJECTABLE;INJECTION	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	CALCIJEX	CALCITRIOL	INJECTABLE;INJECTION	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N018874-001	CALCIJEX	CALCITRIOL	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-09-25
N018874-002	CALCIJEX	CALCITRIOL	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-09-25

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018874-001	CALCIJEX	0.001MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018874-002	CALCIJEX	0.002MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-09-25	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N018874-001	6051567	2019-08-02		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018874-001	6265392	2019-08-02		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018874-001	6274169	2019-08-02		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018874-001	6051567*PED	2020-02-02	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018874-001	6265392*PED	2020-02-02	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018874-001	6274169*PED	2020-02-02	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018874-002	6051567	2019-08-02		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018874-002	6265392	2019-08-02		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018874-002	6274169	2019-08-02		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018874-002	6051567*PED	2020-02-02	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018874-002	6265392*PED	2020-02-02	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018874-002	6274169*PED	2020-02-02	Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N018874-001	6051567*PED	2020-02-02	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018874-001	6265392*PED	2020-02-02	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018874-001	6274169*PED	2020-02-02	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018874-002	6051567*PED	2020-02-02	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018874-002	6265392*PED	2020-02-02	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018874-002	6274169*PED	2020-02-02	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018874-001	6051567*PED	2020-02-02	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018874-001	6265392*PED	2020-02-02	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018874-001	6274169*PED	2020-02-02	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018874-002	6051567*PED	2020-02-02	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018874-002	6265392*PED	2020-02-02	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018874-002	6274169*PED	2020-02-02	Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018874-001	6051567	2019-08-02		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018874-001	6265392	2019-08-02		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018874-001	6274169	2019-08-02		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018874-001	6051567*PED	2020-02-02	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018874-001	6265392*PED	2020-02-02	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018874-001	6274169*PED	2020-02-02	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018874-002	6051567	2019-08-02		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018874-002	6265392	2019-08-02		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018874-002	6274169	2019-08-02		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018874-002	6051567*PED	2020-02-02	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018874-002	6265392*PED	2020-02-02	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018874-002	6274169*PED	2020-02-02	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018874-001	6051567	2019-08-02		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018874-001	6265392	2019-08-02		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018874-001	6274169	2019-08-02		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018874-001	6051567*PED	2020-02-02	Pediatric extension	`b00525d2431f…`

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	bf621b22-b783-416f-aee3-e0dbfdb782ca	2026-07-15	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Calcitriol	CALCITRIOL	ANI Pharmaceuticals, Inc.	bdb9c0d4-bdb3-4174-a4d9-55c423f38476	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Hikma Pharmaceuticals USA Inc.	cdcaffc6-e14e-4607-b77b-fc78a8382f60	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Golden State Medical Supply, Inc.	8465337c-86ca-ea9d-e053-2991aa0ab167	2026-07-06	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Calcitriol	CALCITRIOL	BIONPHARMA INC.	626f23d5-31e6-41ca-a696-191a4f2bc7ef	2026-06-22	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
CALCITRIOL	CALCITRIOL	EPIC PHARMA LLC	554a54a0-3e46-4a9d-8e54-3d853302dbbb	2026-05-13	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Chartwell RX, LLC	36820cd0-7b30-4454-9005-09d71e1d5796	2025-12-09	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	34f53d71-78b0-5237-e063-6294a90a2bbd	2025-05-12	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Rising Pharma Holdings, Inc.	1bd717a4-5fdf-4697-a6b2-9df55c6517bb	2025-04-18	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
CALCITRIOL	CALCITRIOL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	2b48f57a-c023-485d-b846-cab3aaaad486	2025-03-10	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
CALCITRIOL	CALCITRIOL	A-S Medication Solutions	26ac6b4d-9576-4710-856b-aca114ea84cf	2024-12-12	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Vectical	CALCITRIOL	Galderma Laboratories, L.P.	a1567da9-af74-4afd-9ac5-8b53ec5d7cbf	2024-10-24	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Amneal Pharmaceuticals LLC	b1fef137-63c5-4662-8cd9-b9e8b12bacb6	2024-10-23	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	38a676c3-c6c6-4008-87df-f32e1cbaba9b	2024-08-20	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	6c68beb7-1fed-4652-b4e1-672fde0b621d	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Calcitriol	CALCITRIOL	FOSUN PHARMA USA INC	fe7ea4da-bda0-bb00-e053-6394a90a94e7	2024-05-02	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	7e0574e0-3a41-486a-be37-92ab56b7f81f	2023-11-17	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Patrin Pharma, Inc	c5c37779-0c26-438f-b1ca-61cf9915d233	2023-10-02	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Calcitriol	CALCITRIOL	A-S Medication Solutions	b57feb9f-2c5c-4d1c-9330-09c6e9fed95c	2023-10-02	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Hikma Pharmaceuticals USA Inc.	3289b482-8733-484d-b1db-d7f4cdcd1ac2	2023-07-31	Warnings, Adverse reactions	Name fallback generic name: CALCITRIOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
11354	SUPPL	2012-03-27
1111	SUPPL	2012-03-14
16075	SUPPL	2007-07-05
1110	SUPPL	2003-07-30