Application 075303

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

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 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
A075303-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP		1999-05-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075303-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075303-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1999-05-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075303-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075303-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075303-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075303-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075303-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075303-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075303-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075303-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075303-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075303-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075303-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075303-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075303-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075303-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075303-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075303-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075303-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075303-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075303-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075303-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075303-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075303-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075303-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075303-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075303-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075303-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075303-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075303-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075303-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075303-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075303-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075303-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075303-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075303-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075303-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075303-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075303-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075303-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075303-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075303-001	AP	1	`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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Civica, Inc.	d7c53b1c-b6a5-482a-a7c8-7425d9cd9ef8	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075303 application number: ANDA075303 ndc (product): 72572-350
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	5b059ef2-dec0-4cea-b8df-d87df3fea9e2	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075303 application number: ANDA075303 ndc (product): 0143-9320
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	30f9fdef-8781-4327-9a8d-812cb31ff041	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075303 application number: ANDA075303 ndc (product): 0143-9622 ndc (product): 0143-9623
LABETALOL HCl	LABETALOL HCL	HF Acquisition Co LLC, DBA HealthFirst	e76c4b37-4a34-249d-e053-2995a90aa9be	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075303 application number: ANDA075303 ndc (product): 51662-1602

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9320	Labetalol Hydrochloride	Labetalol Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9622	Labetalol Hydrochloride	Labetalol Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9623	Labetalol Hydrochloride	Labetalol Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
51662-1602	LABETALOL HCl	LABETALOL HCl	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1602	LABETALOL HCl	LABETALOL HCl	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
72572-350	Labetalol Hydrochloride	Labetalol Hydrochloride	Civica, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8609	ORIG	1999-05-28