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 4 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	Hikma Pharmaceuticals USA Inc.	5b059ef2-dec0-4cea-b8df-d87df3fea9e2	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	94abdd54-a8e2-4858-8183-6c5d04dbceb5	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	1fce27dd-90a6-45cf-9bd7-13147d3cc0d7	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	706a877b-c388-43e7-b083-518111b288b0	2024-08-06	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	30f9fdef-8781-4327-9a8d-812cb31ff041	2024-07-10	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	30280d40-28df-4c88-93bd-357a7c528906	2024-06-21	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	5a39bb96-4a60-49e8-859c-16bda0fe18e4	2024-06-05	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Gland Pharma Limited	48caf986-3126-48e1-afcd-16d65c9cfe00	2024-05-21	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Fosun Pharma USA Inc.	4a5ffab2-a3b8-411e-992d-7f38d508643a	2024-05-16	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	a007d945-417c-4647-ab03-95ca219d7d38	2024-05-01	Warnings, Adverse reactions	Name fallback brand name: Labetalol hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	143ae21e-c350-4c92-b318-7537f4e46596	2024-04-08	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	83a6e770-207a-46bc-992d-c1ad90d1006d	2023-10-30	Warnings, Adverse reactions	Name fallback brand name: Labetalol hydrochloride generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	1a71964e-e6fa-443e-bfdd-f8852f8cf29e	2023-10-26	Warnings, Adverse reactions	Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	c586ab65-56e8-4a4f-b471-902198d3e58c	2023-10-17	Warnings, Adverse reactions	Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	NorthStar Rx LLC	a2d07ec0-3718-40eb-9d0a-79c557c486b9	2023-04-28	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Cadila Pharmaceuticals Limited	5fba93fc-4580-48c2-a1ec-5d446680adcf	2022-12-09	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol hydrochloride	LABETALOL HYDROCHLORIDE	Proficient Rx LP	c0301841-e209-4242-bace-58a20e6dd01b	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Labetalol hydrochloride generic name: LABETALOL HYDROCHLORIDE
labetalol hydrochloride	LABETALOL HYDROCHLORIDE	Sagent Pharmaceuticals	da8af6c2-d822-4ae5-9c2d-a1d161bdefd0	2022-04-12	Warnings, Adverse reactions	Name fallback brand name: labetalol hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Epic Pharma, LLC	b950655d-a9f8-4ace-bb56-0c7abbca231e	2021-09-30	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Hospira, Inc.	d3579d45-a964-40fe-e3a2-a3a997c8b7b9	2021-05-28	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30859	ORIG	1999-12-29