Application 075431

Type: ANDA
Sponsor: AKORN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	INJECTABLE;INJECTION	5MG/ML	No	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
A075431-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP		1999-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075431-001	AP

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075431-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-11-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075431-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075431-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075431-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075431-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075431-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075431-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075431-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075431-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075431-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075431-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075431-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075431-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075431-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075431-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075431-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075431-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075431-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075431-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075431-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075431-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075431-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075431-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075431-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075431-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075431-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075431-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075431-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075431-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075431-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075431-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075431-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075431-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075431-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075431-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075431-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075431-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075431-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075431-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075431-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075431-001	AP	1	`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 1 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Cardinal Health 107, LLC	63db5b00-e864-4b2d-84f2-00bf35211b9b	2026-09-04	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	REMEDYREPACK INC.	e2e50571-d8c1-43e7-b90f-877ba1c35c9b	2026-08-31	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Coupler LLC	5954cc5c-3e73-e039-e063-6394a90a7d6a	2026-08-18	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride 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 brand name: Labetalol Hydrochloride 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 brand name: LABETALOL HYDROCHLORIDE 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 brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	REMEDYREPACK INC.	5101b8dd-6148-465c-9bba-0209ce823fe5	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	BluePoint Laboratories Inc.	63ede355-42ec-4c52-a941-51e5f6b35ed6	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	9c3bb751-c425-43ff-b530-2460b568b689	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride 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 brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	BluePoint Laboratories	e4562c70-f245-4dbe-8fe1-0bb64a91a315	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride 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 brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	04f9dcdf-4023-48ee-9e7d-ca9366d9db72	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: LABETALOL HYDROCHLORIDE 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 brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	c0c1a162-cd30-4ac9-bc62-407493ed54a5	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Proficient Rx LP	54b75509-824b-4291-818d-71dc1b88915f	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride 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 brand name: Labetalol Hydrochloride 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 brand name: Labetalol Hydrochloride 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 brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	NorthStar Rx LLC	5bd81a8a-a480-4c8d-bd4f-3158412e6a73	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-420	Labetalol Hydrochloride	Labetalol Hydrochloride	Akorn, Inc.	ANDA	Current
17478-420	Labetalol Hydrochloride	Labetalol Hydrochloride	Akorn, Inc.	ANDA	Current
17478-420	Labetalol Hydrochloride	Labetalol Hydrochloride	Akorn	ANDA	Current
17478-420	Labetalol Hydrochloride	Labetalol Hydrochloride	Akorn, Inc.	ANDA	Current
17478-420	Labetalol Hydrochloride	Labetalol Hydrochloride	Akorn	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30883	ORIG	1999-12-29