Application 075816

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALCITRIOL	CALCITRIOL	INJECTABLE;INJECTION	0.001MG/ML	No	No
002	CALCITRIOL	CALCITRIOL	INJECTABLE;INJECTION	0.002MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075816-001	CALCITRIOL	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION			2004-01-16
A075816-002	CALCITRIOL	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2004-01-16

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075816-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	2004-01-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075816-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION	2004-01-16	`74a2ff9319b5…`

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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcitriol	CALCITRIOL	FOSUN PHARMA USA INC	fe7ea4da-bda0-bb00-e053-6394a90a94e7	2024-05-02	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	7e0574e0-3a41-486a-be37-92ab56b7f81f	2023-11-17	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Patrin Pharma, Inc	c5c37779-0c26-438f-b1ca-61cf9915d233	2023-10-02	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL	A-S Medication Solutions	b57feb9f-2c5c-4d1c-9330-09c6e9fed95c	2023-10-02	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Hikma Pharmaceuticals USA Inc.	3289b482-8733-484d-b1db-d7f4cdcd1ac2	2023-07-31	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Aphena Pharma Solutions - Tennessee, LLC	3c40c40c-1627-4bcd-ba35-bee9b952d985	2023-06-13	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
calcitriol	CALCITRIOL	Padagis Israel Pharmaceuticals Ltd	7fa4ab07-3d8e-4300-91f3-b1e17cba8691	2023-01-31	Warnings, Adverse reactions	Name fallback brand name: calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Gland Pharma Limited	d9ba544c-6ca8-410d-a306-51482a8c6848	2022-10-10	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Sun Pharmaceutical Industries, Inc.	97cf7807-3b48-403b-bae2-2fe585946e0c	2022-01-17	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Aphena Pharma Solutions - Tennessee, LLC	adb1b2d5-33a7-4442-9074-cc1a89966528	2021-03-14	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL
Calcitriol	CALCITRIOL	Teva Pharmaceuticals USA, Inc.	ec93b667-aad2-4e3a-adc6-952f070a0c0a	2019-08-01	Warnings, Adverse reactions	Name fallback brand name: Calcitriol generic name: CALCITRIOL

Reported adverse events (FAERS/openFDA)#

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