Application 090699

Type: ANDA
Sponsor: GLAND PHARMA LTD

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 1.

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
A090699-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP		2012-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090699-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090699-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-04-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090699-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090699-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090699-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090699-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090699-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090699-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090699-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090699-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090699-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090699-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090699-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090699-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090699-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090699-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090699-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090699-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090699-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090699-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090699-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090699-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090699-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090699-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090699-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090699-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090699-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090699-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090699-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090699-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090699-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090699-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090699-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090699-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090699-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090699-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090699-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090699-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090699-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090699-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090699-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090699-001	AP	1	`cb3db0bc1861…`

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	Mullan Pharmaceutical Inc.	fb5ef3ba-0a7e-4f41-9547-d734983da0d3	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090699 application number: ANDA090699
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Gland Pharma Limited	48caf986-3126-48e1-afcd-16d65c9cfe00	2024-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090699 application number: ANDA090699 ndc (product): 68083-111
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Fosun Pharma USA Inc.	4a5ffab2-a3b8-411e-992d-7f38d508643a	2024-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090699 application number: ANDA090699 ndc (product): 72266-102 ndc (product): 72266-103
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Fosun Pharma USA Inc.	f18dff28-f6f5-4ecb-9797-25062e247559	2021-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090699 application number: ANDA090699 ndc (product): 72266-103

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-586	Labetalol Hydrochloride	Labetalol Hydrochloride	Alvogen Inc.	ANDA	Current
47781-586	Labetalol Hydrochloride	Labetalol Hydrochloride	Alvogen Inc.	ANDA	Current
47781-586	Labetalol Hydrochloride	Labetalol Hydrochloride	Alvogen Inc.	ANDA	Current
47781-586	Labetalol Hydrochloride	Labetalol Hydrochloride	Alvogen Inc.	ANDA	Current
51991-934	Labetalol Hydrochloride	Labetalol Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-934	Labetalol Hydrochloride	Labetalol Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-935	Labetalol Hydrochloride	Labetalol Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-935	Labetalol Hydrochloride	Labetalol Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
68083-111	Labetalol Hydrochloride	Labetalol Hydrochloride	Gland Pharma Limited	ANDA	Current
68083-111	Labetalol Hydrochloride	Labetalol Hydrochloride	Gland Pharma Limited	ANDA	Current
68083-111	Labetalol Hydrochloride	Labetalol Hydrochloride	Gland Pharma Limited	ANDA	Current
72266-102	Labetalol Hydrochloride	Labetalol Hydrochloride	Fosun Pharma USA Inc.	ANDA	Current
72266-102	Labetalol Hydrochloride	Labetalol Hydrochloride	Fosun Pharma USA Inc.	ANDA	Current
72266-102	Labetalol Hydrochloride	Labetalol Hydrochloride	Fosun Pharma USA Inc.	ANDA	Current
72266-103	Labetalol Hydrochloride	Labetalol Hydrochloride	Fosun Pharma USA Inc.	ANDA	Current
72266-103	Labetalol Hydrochloride	Labetalol Hydrochloride	Fosun Pharma USA Inc.	ANDA	Current
72266-103	Labetalol Hydrochloride	Labetalol Hydrochloride	Fosun Pharma USA Inc.	ANDA	Current
72266-103	Labetalol Hydrochloride	Labetalol Hydrochloride	Fosun Pharma USA Inc.	ANDA	Current
72611-734	labetalol hydrochloride	labetalol hydrochloride	Almaject, Inc.	ANDA	Current
72611-734	labetalol hydrochloride	labetalol hydrochloride	Almaject, Inc.	ANDA	Current
72611-734	labetalol hydrochloride	labetalol hydrochloride	Almaject, Inc.	ANDA	Current
72611-734	labetalol hydrochloride	labetalol hydrochloride	Almaject, Inc.	ANDA	Current
72611-738	labetalol hydrochloride	labetalol hydrochloride	Almaject, Inc.	ANDA	Current
72611-738	labetalol hydrochloride	labetalol hydrochloride	Almaject, Inc.	ANDA	Current
72611-738	labetalol hydrochloride	labetalol hydrochloride	Almaject, Inc.	ANDA	Current
72611-738	labetalol hydrochloride	labetalol hydrochloride	Almaject, Inc.	ANDA	Current