Application 076917

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALCITRIOL	CALCITRIOL	CAPSULE;ORAL	0.25MCG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076917-001	CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2006-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076917-001	AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076917-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076917-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076917-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076917-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076917-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076917-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076917-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076917-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076917-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076917-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076917-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076917-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076917-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076917-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076917-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076917-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076917-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076917-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076917-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076917-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076917-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076917-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076917-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076917-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076917-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076917-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076917-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076917-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076917-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076917-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076917-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076917-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076917-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076917-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076917-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076917-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076917-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076917-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076917-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076917-001	AB	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcitriol	CALCITRIOL	Hikma Pharmaceuticals USA Inc.	cdcaffc6-e14e-4607-b77b-fc78a8382f60	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076917 application number: ANDA076917 ndc (product): 0054-0007
Calcitriol	CALCITRIOL	PD-Rx Pharmaceuticals, Inc.	e1fcb1c7-11a9-4a23-a64a-2c8ce9698321	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076917 application number: ANDA076917 ndc (product): 72789-058
Calcitriol	CALCITRIOL	Aphena Pharma Solutions - Tennessee, LLC	adb1b2d5-33a7-4442-9074-cc1a89966528	2021-03-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076917 application number: ANDA076917 ndc (product): 71610-521

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0007	Calcitriol	Calcitriol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0007	Calcitriol	Calcitriol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0007	Calcitriol	Calcitriol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0007	Calcitriol	Calcitriol	West-Ward Pharmaceuticals Corp.	ANDA	Current
43353-034	Calcitriol	Calcitriol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-034	Calcitriol	Calcitriol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-521	Calcitriol	Calcitriol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72789-058	Calcitriol	Calcitriol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-058	Calcitriol	Calcitriol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-058	Calcitriol	Calcitriol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-058	Calcitriol	Calcitriol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current