Application 075765

Type: ANDA
Sponsor: TEVA

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
A075765-001	CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2001-10-12
A075765-002	CALCITRIOL	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2001-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075765-001	AB
A075765-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`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	A075765-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075765-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075765-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075765-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075765-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075765-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075765-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075765-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075765-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075765-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075765-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075765-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075765-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075765-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075765-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075765-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075765-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075765-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075765-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075765-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075765-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075765-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075765-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075765-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075765-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075765-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075765-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075765-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075765-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075765-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075765-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075765-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075765-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075765-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075765-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075765-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075765-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075765-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075765-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075765-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	34f53d71-78b0-5237-e063-6294a90a2bbd	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075765 application number: ANDA075765
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	38a676c3-c6c6-4008-87df-f32e1cbaba9b	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075765 application number: ANDA075765 ndc (product): 63629-8741
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	6c68beb7-1fed-4652-b4e1-672fde0b621d	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075765 application number: ANDA075765 ndc (product): 63629-8742
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	7e0574e0-3a41-486a-be37-92ab56b7f81f	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075765 application number: ANDA075765 ndc (product): 71335-1594
Calcitriol	CALCITRIOL	Teva Pharmaceuticals USA, Inc.	ec93b667-aad2-4e3a-adc6-952f070a0c0a	2019-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075765 application number: ANDA075765 ndc (product): 0093-7353 ndc (product): 0093-7352

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7352	Calcitriol	Calcitriol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7352	Calcitriol	Calcitriol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7352	Calcitriol	Calcitriol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7353	Calcitriol	Calcitriol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7353	Calcitriol	Calcitriol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7353	Calcitriol	Calcitriol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0179-0245	Calcitriol	Calcitriol	KAISER FOUNDATION HOSPITA	ANDA	Current
63629-8741	Calcitriol	Calcitriol	Bryant Ranch Prepack	ANDA	Current
63629-8741	Calcitriol	Calcitriol	Bryant Ranch Prepack	ANDA	Current
63629-8742	Calcitriol	Calcitriol	Bryant Ranch Prepack	ANDA	Current
63629-8742	Calcitriol	Calcitriol	Bryant Ranch Prepack	ANDA	Current
71335-1594	Calcitriol	Calcitriol	Bryant Ranch Prepack	ANDA	Current
71335-2095	Calcitriol	Calcitriol	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31012	ORIG	2003-04-15