Application 022562

Type: NDA
Sponsor: RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBAGLU	CARGLUMIC ACID	TABLET;ORAL	200MG	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022562-001	CARBAGLU	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022562-001	AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022562-001	ODE-345	2028-01-22

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022562-001	CARBAGLU	200MG	TABLET / ORAL		RLD, RS	2010-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2010-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2010-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2010-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2010-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022562-001	CARBAGLU	200MG	TABLET / ORAL		RLD, RS	2010-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022562-001	CARBAGLU	200MG	TABLET / ORAL		RLD, RS	2010-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022562-001	CARBAGLU	200MG	TABLET / ORAL		RLD, RS	2010-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022562-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022562-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022562-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022562-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022562-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022562-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022562-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022562-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022562-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022562-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022562-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022562-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022562-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022562-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022562-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022562-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022562-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022562-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022562-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022562-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022562-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022562-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022562-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022562-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022562-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022562-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022562-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022562-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022562-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022562-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022562-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022562-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022562-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022562-001	ODE-345	2028-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022562-001	ODE-345	2028-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022562-001	ODE-345	2028-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022562-001	ODE-345	2028-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022562-001	ODE-345	2028-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022562-001	ODE-345	2028-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022562-001	ODE-345	2028-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022562-001	ODE-345	2028-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022562-001	ODE-345	2028-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022562-001	ODE-345	2028-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022562-001	ODE-345	2028-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022562-001	ODE-345	2028-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022562-001	ODE-345	2028-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022562-001	ODE-345	2028-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022562-001	ODE-345	2028-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022562-001	ODE-345	2028-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022562-001	ODE-345	2028-01-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022562-001	ODE-345	2028-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022562-001	ODE-345	2028-01-22	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022562-001	ODE-345	2028-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022562-001	ODE-345	2028-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022562-001	ODE-345	2028-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022562-001	ODE-345	2028-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022562-001	ODE-345	2028-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022562-001	ODE-345	2028-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022562-001	ODE-345	2028-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022562-001	ODE-345	2028-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022562-001	ODE-345	2028-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022562-001	ODE-345	2028-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022562-001	ODE-345	2028-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022562-001	ODE-345	2028-01-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022562-001	ODE-345	2028-01-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022562-001	ODE-345	2028-01-22	`a50c72e98297…`

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
Carbaglu	CARGLUMIC ACID	Recordati Rare Diseases	10175e73-5172-4dde-a508-8a88b7afc0a1	2024-01-25	Adverse reactions	Exact identifier application applno (NDA): 022562 application number: NDA022562 ndc (product): 52276-312

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52276-312	Carbaglu	Carglumic Acid	Recordati Rare Diseases	NDA	Current
52276-312	Carbaglu	Carglumic Acid	Recordati Rare Diseases	NDA	Current
52276-312	Carbaglu	Carglumic Acid	Recordati Rare Diseases	NDA	Current
52276-312	Carbaglu	Carglumic Acid	Orphan Europe, SARL	NDA	Current
52276-312	Carbaglu	Carglumic Acid	Orphan Europe, SARL	NDA	Current
52276-312	Carbaglu	Carglumic Acid	Recordati Rare Diseases	NDA	Current
52276-312	Carbaglu	Carglumic Acid	Recordati Rare Diseases	NDA	Current
52276-312	Carbaglu	Carglumic Acid	Recordati Rare Diseases	NDA	Current
52276-312	Carbaglu	Carglumic Acid	Recordati Rare Diseases	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77267	SUPPL	2024-01-23
77252	SUPPL	2024-01-22
68313	SUPPL	2021-08-06
68301	SUPPL	2021-08-06
66012	SUPPL	2021-01-28
66011	SUPPL	2021-01-28
65967	SUPPL	2021-01-25
65966	SUPPL	2021-01-25
64425	SUPPL	2020-08-27
61490	SUPPL	2019-12-31
61457	SUPPL	2019-12-26
50449	SUPPL	2017-11-17
50437	SUPPL	2017-11-17
29860	SUPPL	2013-08-06
38840	SUPPL	2013-08-05
22057	ORIG	2010-04-20
29859	ORIG	2010-03-22
38839	ORIG	2010-03-18