Application 091356

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALCITRIOL	CALCITRIOL	CAPSULE;ORAL	0.25MCG	No	No
002	CALCITRIOL	CALCITRIOL	CAPSULE;ORAL	0.5MCG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091356-001	CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12
A091356-002	CALCITRIOL	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091356-001	AB
A091356-002	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 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	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2014-12-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2014-12-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2014-12-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2014-12-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2014-12-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2014-12-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A091356-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091356-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091356-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091356-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091356-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091356-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091356-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091356-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091356-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091356-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091356-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091356-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091356-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091356-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091356-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091356-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091356-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091356-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091356-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091356-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091356-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091356-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091356-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091356-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091356-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091356-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091356-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091356-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091356-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091356-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091356-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091356-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091356-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091356-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091356-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091356-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091356-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091356-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091356-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091356-002	AB	1	`782e0a99824c…`

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
Calcitriol	CALCITRIOL CAPSULES 0.25 MCG	Strides Pharma Science Limited	bebefb2a-7365-48e2-9681-83ed4b41e26e	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356 ndc (product): 64380-724 ndc (product): 64380-723
Calcitriol	CALCITRIOL CAPSULES 0.25 MCG	Cardinal Health 107, LLC	32205cfc-7939-4105-a4b9-2ed327c5e0cc	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356 ndc (product): 55154-8186
Calcitriol	CALCITRIOL	Chartwell RX, LLC	36820cd0-7b30-4454-9005-09d71e1d5796	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356
Calcitriol	CALCITRIOL CAPSULES 0.25 MCG	American Health Packaging	261398eb-80b8-4c3d-9d2b-3a8004347a75	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356 ndc (product): 60687-345
CALCITRIOL	CALCITRIOL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	2b48f57a-c023-485d-b846-cab3aaaad486	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356 ndc (product): 23155-663 ndc (product): 23155-662
Calcitriol	CALCITRIOL CAPSULES 0.25 MCG	Aphena Pharma Solutions - Tennessee, LLC	29b8cc1f-0491-0a95-e063-6294a90a223d	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356
CALCITRIOL	CALCITRIOL	A-S Medication Solutions	26ac6b4d-9576-4710-856b-aca114ea84cf	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356
Calcitriol	CALCITRIOL CAPSULES 0.25 MCG	Bryant Ranch Prepack	3637da5e-55cf-40ed-9bea-18c27b595627	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0723	Calcitriol	Calcitriol 0.25 mcg	Atlantic Biologicals Corps	ANDA	Current
23155-662	CALCITRIOL	CALCITRIOL	Avet Pharmaceuticals Inc.	ANDA	Current
23155-662	CALCITRIOL	CALCITRIOL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-662	CALCITRIOL	CALCITRIOL	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-663	CALCITRIOL	CALCITRIOL	Avet Pharmaceuticals Inc.	ANDA	Current
23155-663	CALCITRIOL	CALCITRIOL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-663	CALCITRIOL	CALCITRIOL	Heritage Pharmaceuticals Inc.	ANDA	Current
55154-8186	Calcitriol	Calcitriol Capsules 0.25 mcg	Cardinal Health	ANDA	Current
55154-8186	Calcitriol	Calcitriol Capsules 0.25 mcg	Cardinal Health 107, LLC	ANDA	Current
60687-345	Calcitriol	Calcitriol Capsules 0.25 mcg	American Health Packaging	ANDA	Current
60687-345	Calcitriol	Calcitriol Capsules 0.25 mcg	American Health Packaging	ANDA	Current
60687-345	Calcitriol	Calcitriol Capsules 0.25 mcg	American Health Packaging	ANDA	Current
64380-723	Calcitriol	Calcitriol Capsules 0.25 mcg	Strides Pharma Science Limited	ANDA	Current
64380-723	Calcitriol	Calcitriol Capsules 0.25 mcg	Strides Shasun Limited	ANDA	Current
64380-723	Calcitriol	Calcitriol Capsules 0.25 mcg	Strides Pharma Science Limited	ANDA	Current
64380-723	Calcitriol	Calcitriol Capsules 0.25 mcg	Strides Pharma Science Limited	ANDA	Current
64380-724	Calcitriol	Calcitriol Capsules 0.5 mcg	Strides Pharma Science Limited	ANDA	Current
64380-724	Calcitriol	Calcitriol Capsules 0.5 mcg	Strides Shasun Limited	ANDA	Current
64380-724	Calcitriol	Calcitriol Capsules 0.5 mcg	Strides Pharma Science Limited	ANDA	Current
64380-724	Calcitriol	Calcitriol Capsules 0.5 mcg	Strides Pharma Science Limited	ANDA	Current