Application 211041

Type: ANDA
Sponsor: NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITISINONE	NITISINONE	CAPSULE;ORAL	2MG	No	No
002	NITISINONE	NITISINONE	CAPSULE;ORAL	5MG	No	No
003	NITISINONE	NITISINONE	CAPSULE;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211041-001	NITISINONE	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26
A211041-002	NITISINONE	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26
A211041-003	NITISINONE	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211041-001	AB
A211041-002	AB
A211041-003	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
2026-08-18 06:07:40	2026-07	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`1e350fbaab3a…`

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
2026-08-18 06:07:40	2026-07	A211041-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211041-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211041-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211041-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211041-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211041-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211041-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211041-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211041-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211041-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211041-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211041-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211041-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211041-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211041-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211041-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211041-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211041-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211041-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211041-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211041-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211041-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211041-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211041-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211041-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211041-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211041-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211041-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211041-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211041-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211041-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211041-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211041-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211041-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211041-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211041-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211041-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211041-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211041-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211041-001	AB	1	`1e350fbaab3a…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitisinone	NITISINONE	Par Health USA, LLC	437868f5-1c9e-4b0f-8a03-77df8ac0900d	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211041 application number: ANDA211041 ndc (product): 0254-3020 ndc (product): 0254-3021 ndc (product): 0254-3022
Nitisinone	NITISINONE	Bryant Ranch Prepack	c1b3adc8-02fa-4e22-8c05-8f32b586e53f	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211041 application number: ANDA211041 ndc (product): 63629-2233
Nitisinone	NITISINONE	Bryant Ranch Prepack	8cec0318-9f55-4340-b14b-588635619251	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211041 application number: ANDA211041 ndc (product): 63629-2235
Nitisinone	NITISINONE	Bryant Ranch Prepack	b7c38003-6899-4508-a69a-aef1231de22c	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211041 application number: ANDA211041 ndc (product): 63629-2234

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0254-3020	Nitisinone	Nitisinone	Par Pharmaceutical, Inc.	ANDA	Current
0254-3020	Nitisinone	Nitisinone	Par Pharmaceutical, Inc.	ANDA	Current
0254-3021	Nitisinone	Nitisinone	Par Pharmaceutical, Inc.	ANDA	Current
0254-3021	Nitisinone	Nitisinone	Par Pharmaceutical, Inc.	ANDA	Current
0254-3022	Nitisinone	Nitisinone	Par Pharmaceutical, Inc.	ANDA	Current
0254-3022	Nitisinone	Nitisinone	Par Pharmaceutical, Inc.	ANDA	Current
63629-2233	Nitisinone	Nitisinone	Bryant Ranch Prepack	ANDA	Current
63629-2233	Nitisinone	Nitisinone	Bryant Ranch Prepack	ANDA	Current
63629-2234	Nitisinone	Nitisinone	Bryant Ranch Prepack	ANDA	Current
63629-2234	Nitisinone	Nitisinone	Bryant Ranch Prepack	ANDA	Current
63629-2235	Nitisinone	Nitisinone	Bryant Ranch Prepack	ANDA	Current
63629-2235	Nitisinone	Nitisinone	Bryant Ranch Prepack	ANDA	Current
70954-008	Nitisinone	Nitisinone	Novitium Pharma LLC	ANDA	Current
70954-008	Nitisinone	Nitisinone	Novitium Pharma LLC	ANDA	Current
70954-009	Nitisinone	Nitisinone	Novitium Pharma LLC	ANDA	Current
70954-009	Nitisinone	Nitisinone	Novitium Pharma LLC	ANDA	Current
70954-010	Nitisinone	Nitisinone	Novitium Pharma LLC	ANDA	Current
70954-010	Nitisinone	Nitisinone	Novitium Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60138	ORIG	2019-09-27