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LABETALOL HYDROCHLORIDE	INJECTABLE;INJECTION	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 43.

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N019425-001	TRANDATE	LABETALOL HYDROCHLORIDE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-12-31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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`84e616aacf4f…`
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N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`caaa826d4ba7…`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UTC	2026-02	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`011fe1cb6892…`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of this ZIP	2025-12	N019425-001	TRANDATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-12-31	`31067a03dcf5…`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…`

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 2 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	REMEDYREPACK INC.	ae5d7b3b-e444-48d3-9d85-9b07319f9374	2026-04-10	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Advagen Pharma Ltd	106a0959-5830-489f-ba60-afd4eb0fac36	2026-04-02	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Advagen Pharma Ltd	1c680447-b43a-4ff1-bc64-2c2174ca1c9a	2026-04-02	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	d4364caf-46c6-4144-9ba5-2c561e4f3a95	2026-03-26	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	3909ac9e-6818-4c5d-ad0e-52865a574b45	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	35e7bce0-d9ff-4f8b-95c5-218da2a2d929	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	f7f7fade-98a6-4741-bfb9-f1eb54ad4565	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	d207396a-068e-4229-88cc-a1a4df7aeff2	2026-03-07	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	b4a5f170-a400-4986-8c64-f55d0413f0f6	2026-03-07	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	bf84ebae-3c91-4448-b1db-8e5ed3053866	2026-03-05	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Major Pharmaceuticals	35b5fd32-581d-427b-9a13-b7a02846d21d	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Civica, Inc.	d7c53b1c-b6a5-482a-a7c8-7425d9cd9ef8	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	5942a5a8-c3c1-4ecb-921e-9bc92393bdf8	2026-03-02	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	ed0188ba-3fd3-4680-a829-ba242a115fab	2026-02-25	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Biocon Pharma Inc.	27e4ab03-c17b-4268-912c-e45a5e8f8dd8	2026-02-19	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	0db22a64-1863-4188-850b-273ea746e327	2026-02-09	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	d8b69cc9-bdee-4e24-a3d8-d1887de5a17d	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	6f919513-500e-4a05-935e-b6fc1615368a	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Northwind Health Company, LLC	faf7a1ff-f18a-8ca7-e053-6394a90a1b1f	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Innogenix, Inc.	82fc2d64-0572-4a9b-94fc-f6eb8d930c54	2025-12-23	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

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