Application 212390

Type: ANDA
Sponsor: DIPHARMA

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
004	NITISINONE	NITISINONE	CAPSULE;ORAL	20MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212390-001	NITISINONE	NITISINONE	2MG	CAPSULE / ORAL	AB	2022-05-26
A212390-002	NITISINONE	NITISINONE	5MG	CAPSULE / ORAL	AB	2022-05-26
A212390-003	NITISINONE	NITISINONE	10MG	CAPSULE / ORAL	AB	2022-05-26
A212390-004	NITISINONE	NITISINONE	20MG	CAPSULE / ORAL	AB	2023-04-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A212390-001	AB
A212390-002	AB
A212390-003	AB
A212390-004	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 · 113 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	A212390-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2022-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212390-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2022-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212390-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2022-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212390-004	NITISINONE	20MG	CAPSULE / ORAL	AB	2023-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212390-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2022-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212390-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2022-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212390-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2022-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212390-004	NITISINONE	20MG	CAPSULE / ORAL	AB	2023-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212390-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2022-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212390-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2022-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212390-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2022-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212390-004	NITISINONE	20MG	CAPSULE / ORAL	AB	2023-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212390-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2022-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212390-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2022-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212390-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2022-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212390-004	NITISINONE	20MG	CAPSULE / ORAL	AB	2023-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212390-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2022-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212390-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2022-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212390-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2022-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212390-004	NITISINONE	20MG	CAPSULE / ORAL	AB	2023-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212390-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2022-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212390-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2022-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212390-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2022-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212390-004	NITISINONE	20MG	CAPSULE / ORAL	AB	2023-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212390-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2022-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212390-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2022-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212390-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2022-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212390-004	NITISINONE	20MG	CAPSULE / ORAL	AB	2023-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212390-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2022-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212390-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2022-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212390-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2022-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212390-004	NITISINONE	20MG	CAPSULE / ORAL	AB	2023-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212390-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2022-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212390-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2022-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212390-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2022-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212390-004	NITISINONE	20MG	CAPSULE / ORAL	AB	2023-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212390-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2022-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212390-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2022-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212390-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2022-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212390-004	NITISINONE	20MG	CAPSULE / ORAL	AB	2023-04-27	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 113 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	A212390-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212390-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212390-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212390-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212390-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212390-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212390-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212390-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212390-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212390-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212390-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212390-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212390-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212390-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212390-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212390-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212390-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212390-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212390-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212390-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212390-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212390-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212390-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212390-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212390-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212390-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212390-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212390-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212390-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212390-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212390-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212390-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212390-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212390-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212390-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212390-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212390-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212390-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212390-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212390-004	AB	1	`d8e5a09893c0…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitisinone	NITISINONE	Analog Pharma	645c8387-30d5-4a86-a5d8-2f6b5df6d5f0	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212390 application number: ANDA212390 ndc (product): 70505-205 ndc (product): 70505-202 ndc (product): 70505-210

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70505-202	Nitisinone	Nitisinone	Analog Pharma	ANDA	Current
70505-202	Nitisinone	Nitisinone	Analog Pharma	ANDA	Current
70505-205	Nitisinone	Nitisinone	Analog Pharma	ANDA	Current
70505-205	Nitisinone	Nitisinone	Analog Pharma	ANDA	Current
70505-210	Nitisinone	Nitisinone	Analog Pharma	ANDA	Current
70505-210	Nitisinone	Nitisinone	Analog Pharma	ANDA	Current