Application 078066

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALCITRIOL	CALCITRIOL	INJECTABLE;INJECTION	0.001MG/ML	No	Yes
002	CALCITRIOL	CALCITRIOL	INJECTABLE;INJECTION	0.002MG/ML	No	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
A078066-001	CALCITRIOL	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29
A078066-002	CALCITRIOL	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078066-001	AP

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	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION		RS	2008-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078066-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078066-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078066-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078066-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078066-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078066-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078066-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078066-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078066-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078066-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078066-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078066-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078066-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078066-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078066-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078066-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078066-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A078066-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078066-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078066-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078066-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078066-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078066-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078066-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078066-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078066-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078066-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078066-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078066-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078066-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078066-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078066-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078066-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078066-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078066-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078066-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078066-001	AP	1	`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 2 · 32 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 brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL	ANI Pharmaceuticals, Inc.	bdb9c0d4-bdb3-4174-a4d9-55c423f38476	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Hikma Pharmaceuticals USA Inc.	cdcaffc6-e14e-4607-b77b-fc78a8382f60	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Golden State Medical Supply, Inc.	8465337c-86ca-ea9d-e053-2991aa0ab167	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL CAPSULES 0.25 MCG	Strides Pharma Science Limited	bebefb2a-7365-48e2-9681-83ed4b41e26e	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Calcitriol
Calcitriol	CALCITRIOL	BIONPHARMA INC.	626f23d5-31e6-41ca-a696-191a4f2bc7ef	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
CALCITRIOL	CALCITRIOL	EPIC PHARMA LLC	554a54a0-3e46-4a9d-8e54-3d853302dbbb	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: CALCITRIOL generic name: CALCITRIOL
Calcitriol	CALCITRIOL CAPSULES 0.25 MCG	Cardinal Health 107, LLC	32205cfc-7939-4105-a4b9-2ed327c5e0cc	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Calcitriol
Calcitriol	CALCITRIOL	Chartwell RX, LLC	36820cd0-7b30-4454-9005-09d71e1d5796	2025-12-09	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL CAPSULES 0.25 MCG	American Health Packaging	261398eb-80b8-4c3d-9d2b-3a8004347a75	2025-11-13	Warnings, Adverse reactions	Name fallback brand name: Calcitriol
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	34f53d71-78b0-5237-e063-6294a90a2bbd	2025-05-12	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Rising Pharma Holdings, Inc.	1bd717a4-5fdf-4697-a6b2-9df55c6517bb	2025-04-18	Warnings, Adverse reactions	Name fallback brand name: Calcitriol 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 brand name: CALCITRIOL generic name: CALCITRIOL
Calcitriol	CALCITRIOL	PD-Rx Pharmaceuticals, Inc.	e1fcb1c7-11a9-4a23-a64a-2c8ce9698321	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL CAPSULES 0.25 MCG	Aphena Pharma Solutions - Tennessee, LLC	29b8cc1f-0491-0a95-e063-6294a90a223d	2024-12-20	Warnings, Adverse reactions	Name fallback brand name: Calcitriol
CALCITRIOL	CALCITRIOL	A-S Medication Solutions	26ac6b4d-9576-4710-856b-aca114ea84cf	2024-12-12	Warnings, Adverse reactions	Name fallback brand name: CALCITRIOL 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 brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	38a676c3-c6c6-4008-87df-f32e1cbaba9b	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	6c68beb7-1fed-4652-b4e1-672fde0b621d	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-831	Calcitriol	Calcitriol	Akorn, Inc.	ANDA	Current
17478-831	Calcitriol	Calcitriol	Akorn	ANDA	Current
17478-831	Calcitriol	Calcitriol	Akorn, Inc.	ANDA	Current
17478-831	Calcitriol	Calcitriol	Akorn	ANDA	Current
17478-931	Calcitriol	Calcitriol	Akorn, Inc.	ANDA	Current
17478-931	Calcitriol	Calcitriol	Akorn	ANDA	Current
17478-931	Calcitriol	Calcitriol	Akorn	ANDA	Current
17478-931	Calcitriol	Calcitriol	Akorn, Inc.	ANDA	Current
17478-932	Calcitriol	Calcitriol	Akorn, Inc.	ANDA	Current
17478-932	Calcitriol	Calcitriol	Akorn	ANDA	Current
17478-932	Calcitriol	Calcitriol	Akorn	ANDA	Current
17478-932	Calcitriol	Calcitriol	Akorn, Inc.	ANDA	Current