Application 202539

Type: ANDA
Sponsor: BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PARICALCITOL	PARICALCITOL	CAPSULE;ORAL	1MCG	No	No
002	PARICALCITOL	PARICALCITOL	CAPSULE;ORAL	2MCG	No	No
003	PARICALCITOL	PARICALCITOL	CAPSULE;ORAL	4MCG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202539-001	PARICALCITOL	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27
A202539-002	PARICALCITOL	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27
A202539-003	PARICALCITOL	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202539-001	AB
A202539-002	AB
A202539-003	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 4 · 123 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	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202539-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2014-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202539-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2014-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202539-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2014-03-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A202539-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202539-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202539-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202539-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202539-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202539-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202539-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202539-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202539-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202539-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202539-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202539-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202539-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202539-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202539-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202539-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202539-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202539-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202539-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202539-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202539-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202539-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202539-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202539-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202539-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202539-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202539-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202539-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202539-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202539-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202539-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202539-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202539-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202539-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202539-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202539-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202539-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202539-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202539-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202539-001	AB	1	`8072bd15b7f6…`

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
Paricalcitol	PARICALCITOL	Bryant Ranch Prepack	664253fb-d99d-4af6-971b-95c0087406d9	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202539 application number: ANDA202539
Paricalcitol	PARICALCITOL	Bryant Ranch Prepack	22a0d467-9881-458f-8b1c-1186feb96ee4	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202539 application number: ANDA202539 ndc (product): 63629-2452
Paricalcitol	PARICALCITOL	Bryant Ranch Prepack	52ca3d88-e85d-44a9-8aa7-eb25a8a73f6f	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202539 application number: ANDA202539 ndc (product): 63629-2453
Paricalcitol	PARICALCITOL	Bryant Ranch Prepack	d62d977a-bbfc-454a-a4a9-017a9f525574	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202539 application number: ANDA202539
Paricalcitol	PARICALCITOL	Bionpharma Inc.	755476e5-62a2-4f01-92a3-307e192ad42c	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202539 application number: ANDA202539 ndc (product): 69452-146 ndc (product): 69452-145 ndc (product): 69452-147

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10888-5001	Paricalcitol	Paricalcitol	Banner Pharmacaps	ANDA	Current
10888-5002	Paricalcitol	Paricalcitol	Banner Pharmacaps	ANDA	Current
10888-5003	Paricalcitol	Paricalcitol	Banner Pharmacaps	ANDA	Current
60429-481	Paricalcitol	Paricalcitol	Golden State Medical Supply, Inc.	ANDA	Current
60429-481	PARICALCITOL	PARICALCITOL	Golden State Medical Supply, Inc.	ANDA	Current
60429-482	Paricalcitol	Paricalcitol	Golden State Medical Supply, Inc.	ANDA	Current
60429-482	PARICALCITOL	PARICALCITOL	Golden State Medical Supply, Inc.	ANDA	Current
60429-483	Paricalcitol	Paricalcitol	Golden State Medical Supply, Inc.	ANDA	Current
60429-483	PARICALCITOL	PARICALCITOL	Golden State Medical Supply, Inc.	ANDA	Current
60429-836	Paricalcitol	Paricalcitol	Golden State Medical Supply, Inc.	ANDA	Current
60429-836	Paricalcitol	Paricalcitol	Golden State Medical Supply, Inc.	ANDA	Current
60429-837	Paricalcitol	Paricalcitol	Golden State Medical Supply, Inc.	ANDA	Current
60429-837	Paricalcitol	Paricalcitol	Golden State Medical Supply, Inc.	ANDA	Current
60429-838	Paricalcitol	Paricalcitol	Golden State Medical Supply, Inc.	ANDA	Current
63629-2452	Paricalcitol	Paricalcitol	Bryant Ranch Prepack	ANDA	Current
63629-2452	Paricalcitol	Paricalcitol	Bryant Ranch Prepack	ANDA	Current
63629-2453	Paricalcitol	Paricalcitol	Bryant Ranch Prepack	ANDA	Current
63629-2453	Paricalcitol	Paricalcitol	Bryant Ranch Prepack	ANDA	Current
69387-103	PARICALCITOL	PARICALCITOL	Banner Life Sciences LLC.	ANDA	Current
69387-104	PARICALCITOL	PARICALCITOL	Banner Life Sciences LLC.	ANDA	Current
69387-105	PARICALCITOL	PARICALCITOL	Banner Life Sciences LLC.	ANDA	Current
69452-145	Paricalcitol	Paricalcitol	Bionpharma Inc.	ANDA	Current
69452-146	Paricalcitol	Paricalcitol	Bionpharma Inc.	ANDA	Current
69452-147	Paricalcitol	Paricalcitol	Bionpharma Inc.	ANDA	Current