Application 075355

Type: ANDA
Sponsor: APOTHECON

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
A075355-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION			1999-11-29

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075355-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	1999-11-29	`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 3 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	Method Pharmaceuticals, LLC	733d6e32-ac90-4796-bf25-9d5887c897a5	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	99a715a0-4579-410c-b102-7ef6fab8db55	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Redpharm Drug	32525ed4-3cca-2b99-e063-6294a90a6c66	2025-12-13	Warnings, Adverse reactions	Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Chartwell RX, LLC	ac439c08-1e47-4306-8308-b31d7a1a443c	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Mullan Pharmaceutical Inc.	fb5ef3ba-0a7e-4f41-9547-d734983da0d3	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	e6836a01-220d-4b69-9b4a-c919daeb6ece	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	0dcd514d-bda8-484b-8cf1-f5656aaab9ce	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	20c26652-52da-4eef-8486-f91eb30e9ff7	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	dafa7411-2857-4f5a-a587-4367cfbe2bfa	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	dbf1e4c7-7c0c-4f2f-8cad-96bc6b800cfc	2025-10-06	Warnings, Adverse reactions	Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Macleods Pharmaceuticals Limited	366134cd-6244-45fc-99f1-0193a0221b3a	2025-10-06	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	RedPharm Drug	1e1b7355-4802-d277-e063-6394a90aef44	2025-07-29	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	NuCare Pharmaceuticals , Inc.	3aff731f-1eec-19b5-e063-6294a90a3143	2025-07-28	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol HCL	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	312dde0d-5147-483e-968f-4e0d46114176	2025-06-19	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Caplin Steriles Limited	77152699-1ca8-442a-8cb4-80b0ffbec6f2	2025-02-14	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	5faacbcc-f88f-42f7-8702-791ee82c4d18	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	American Health Packaging	3004aa59-288c-4971-b77b-78789715ef5a	2024-12-30	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Zydus Lifesciences Limited	a3c0cc1e-1c01-4009-afdc-d35a66546aec	2024-11-30		Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	64cd636d-8b48-4f29-b41d-4a048335793e	2024-11-20	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL	Marlex Pharmaceuticals Inc	28c91727-e5a8-48b3-a4df-d7bec8feda40	2024-10-07	Warnings, Adverse reactions	Name fallback brand 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
30859	ORIG	1999-12-29