Application 213729

Type: ANDA
Sponsor: NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARGLUMIC ACID	CARGLUMIC ACID	TABLET, FOR SUSPENSION;ORAL	200MG	No	No

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

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
A213729-001	CARGLUMIC ACID	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB		2021-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213729-001	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.

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	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213729-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213729-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213729-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213729-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213729-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213729-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213729-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213729-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213729-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213729-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213729-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213729-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213729-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213729-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213729-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213729-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213729-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213729-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213729-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213729-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213729-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213729-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213729-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213729-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213729-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213729-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213729-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213729-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213729-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213729-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213729-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213729-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213729-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213729-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213729-001	CGT	2022-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213729-001	CGT	2022-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213729-001	CGT	2022-06-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213729-001	CGT	2022-06-18	`bb7c543d1eb4…`
2023-01-26 05:58 UTC	2023-01	A213729-001	CGT	2022-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213729-001	CGT	2022-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213729-001	CGT	2022-06-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213729-001	CGT	2022-06-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213729-001	CGT	2022-06-18	`cb3db0bc1861…`

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
Carglumic Acid	CARGLUMIC ACID	Eton Pharmaceuticals, Inc.	591f95ca-3d99-4fb6-a402-e5a383a746d0	2026-03-03	Adverse reactions	Exact identifier application applno (ANDA): 213729 application number: ANDA213729 ndc (product): 71863-114

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70954-120	Carglumic Acid	Carglumic Acid	Novitium Pharma LLC	ANDA	Current
71863-114	Carglumic Acid	Carglumic Acid	Eton Pharmaceuticals, Inc.	ANDA	Current
71863-114	Carglumic Acid	Carglumic Acid	Eton Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69690	ORIG	2021-12-20