Application 019425

Type: NDA
Sponsor: SEBELA IRELAND LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRANDATE	LABETALOL HYDROCHLORIDE	INJECTABLE;INJECTION	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N019425-001	TRANDATE	LABETALOL HYDROCHLORIDE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-12-31

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 · 42 observed 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	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019425-001	TRANDATE	5MG/ML	INJECTABLE / INJECTION	RLD	1985-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019425-001	TRANDATE	5MG/ML	INJECTABLE / INJECTION	RLD	1985-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`e64feba35796…`

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 5 · 86 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Coupler LLC	5954cc5c-3e73-e039-e063-6394a90a7d6a	2026-08-18	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Hospira, Inc.	abfc6b75-1ed5-41f1-0484-4597488237bc	2026-07-13	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	30281c4d-2fd1-167a-e063-6294a90a77c4	2026-06-30	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Onesource Specialty Pharma Limited	6cb2c117-584c-4440-acfb-e4b1af4dc509	2026-06-29	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	ed2293f8-2b82-c3db-e053-2995a90ad46c	2026-06-22	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	REMEDYREPACK INC.	5101b8dd-6148-465c-9bba-0209ce823fe5	2026-06-11	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	BluePoint Laboratories Inc.	63ede355-42ec-4c52-a941-51e5f6b35ed6	2026-06-08	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	9c3bb751-c425-43ff-b530-2460b568b689	2026-06-05	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	fffb7c59-ad92-4e74-850d-d94d42b7fdc9	2026-06-04	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	BluePoint Laboratories	e4562c70-f245-4dbe-8fe1-0bb64a91a315	2026-06-04	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Cardinal Health 107, LLC	1b96ddc9-d0c3-488a-a113-66491fd3d899	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	04f9dcdf-4023-48ee-9e7d-ca9366d9db72	2026-05-22	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Cardinal Health 107, LLC	d3ca153c-25b2-4506-91bd-bf9d6a4c01fe	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	c0c1a162-cd30-4ac9-bc62-407493ed54a5	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Proficient Rx LP	54b75509-824b-4291-818d-71dc1b88915f	2026-05-01	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Golden State Medical Supply, Inc.	d5ce687f-4a37-d3e6-e053-2995a90aa974	2026-04-16	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	371cb135-6a5f-433d-a87d-ab8521c4aa6d	2026-04-16	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	f9af85d3-a5a7-49d6-aff6-1ca2b2d75450	2026-04-16	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	NorthStar Rx LLC	5bd81a8a-a480-4c8d-bd4f-3158412e6a73	2026-04-13	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	REMEDYREPACK INC.	ae5d7b3b-e444-48d3-9d85-9b07319f9374	2026-04-10	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
17390	SUPPL	2010-11-30
33741	SUPPL	2010-11-22