Application 214253

Type: NDA
Sponsor: CUSTOPHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	SOLUTION;INTRAVENOUS	100MCG/ML	Yes	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
N214253-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS		RLD, RS	2021-05-17

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214253-001	11154498	2036-07-20		Drug product	2021-10-27

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214253-001	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-17	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214253-001	11154498	2036-07-20	Drug product	2021-10-27	`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
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Hikma Pharmaceuticals USA Inc.	6279390b-ee61-4ef9-ac15-25537ca783c1	2024-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 214253 application number: NDA214253 ndc (product): 24201-002

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24201-002	Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Hikma Pharmaceuticals USA Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68964	ORIG	2021-10-12
67540	ORIG	2021-05-18
67535	ORIG	2021-05-18