Application 204948

Type: ANDA
Sponsor: MARKSANS PHARMA

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
A204948-001	PARICALCITOL	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2016-10-07
A204948-002	PARICALCITOL	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2016-10-07
A204948-003	PARICALCITOL	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2016-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204948-001	AB
A204948-002	AB
A204948-003	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	A204948-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2016-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204948-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2016-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204948-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2016-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204948-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2016-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204948-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2016-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204948-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2016-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204948-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2016-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204948-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2016-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204948-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2016-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204948-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2016-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204948-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2016-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204948-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2016-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204948-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2016-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204948-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2016-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204948-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2016-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204948-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2016-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204948-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2016-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204948-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2016-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204948-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2016-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204948-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2016-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204948-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2016-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204948-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2016-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204948-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2016-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204948-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2016-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204948-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2016-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204948-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2016-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204948-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2016-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204948-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2016-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204948-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2016-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204948-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2016-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204948-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2016-10-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204948-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2016-10-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204948-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2016-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204948-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2016-10-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204948-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2016-10-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204948-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2016-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204948-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2016-10-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204948-002	PARICALCITOL	2MCG	CAPSULE / ORAL	AB	2016-10-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204948-003	PARICALCITOL	4MCG	CAPSULE / ORAL	AB	2016-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204948-001	PARICALCITOL	1MCG	CAPSULE / ORAL	AB	2016-10-07	`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	A204948-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204948-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204948-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204948-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204948-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204948-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204948-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204948-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204948-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204948-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204948-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204948-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204948-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204948-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204948-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204948-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204948-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204948-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204948-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204948-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204948-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204948-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204948-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204948-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204948-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204948-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204948-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204948-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204948-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204948-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204948-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204948-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204948-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204948-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204948-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204948-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204948-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204948-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204948-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204948-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paricalcitol	PARICALCITOL	TIME CAP LABORATORIES, INC	f593b575-7537-4531-87fc-c1b0814fd018	2022-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204948 application number: ANDA204948 ndc (product): 49483-689 ndc (product): 49483-687 ndc (product): 49483-688
Paricalcitol	PARICALCITOL	MARKSANS PHARMA LIMITED	0fbaff52-f08f-42b7-8e46-c7214112901a	2017-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204948 application number: ANDA204948 ndc (product): 25000-017 ndc (product): 25000-014 ndc (product): 25000-012

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25000-012	Paricalcitol	Paricalcitol	MARKSANS PHARMA LIMITED	ANDA	Current
25000-014	Paricalcitol	Paricalcitol	MARKSANS PHARMA LIMITED	ANDA	Current
25000-017	Paricalcitol	Paricalcitol	MARKSANS PHARMA LIMITED	ANDA	Current
49483-687	PARICALCITOL	PARICALCITOL	TIME CAP LABORATORIES, INC	ANDA	Current
49483-687	PARICALCITOL	PARICALCITOL	TIME CAP LABORATORIES, INC	ANDA	Current
49483-687	Paricalcitol	Paricalcitol	TIME CAP LABORATORIES, INC	ANDA	Current
49483-688	PARICALCITOL	PARICALCITOL	TIME CAP LABORATORIES, INC	ANDA	Current
49483-688	PARICALCITOL	PARICALCITOL	TIME CAP LABORATORIES, INC	ANDA	Current
49483-688	Paricalcitol	Paricalcitol	TIME CAP LABORATORIES, INC	ANDA	Current
49483-689	PARICALCITOL	PARICALCITOL	TIME CAP LABORATORIES, INC	ANDA	Current
49483-689	PARICALCITOL	PARICALCITOL	TIME CAP LABORATORIES, INC	ANDA	Current
49483-689	Paricalcitol	Paricalcitol	TIME CAP LABORATORIES, INC	ANDA	Current