Application 207743

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	200MG	No	No
003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207743-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19
A207743-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2017-09-19
A207743-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A207743-001	AB
A207743-002	AB
A207743-003	AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2017-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A207743-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207743-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207743-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207743-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207743-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207743-001	AB	1	`1e350fbaab3a…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	BluePoint Laboratories Inc.	63ede355-42ec-4c52-a941-51e5f6b35ed6	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207743 application number: ANDA207743 ndc (product): 68001-383 ndc (product): 68001-382 ndc (product): 68001-381
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	9c3bb751-c425-43ff-b530-2460b568b689	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207743 application number: ANDA207743 ndc (product): 71335-1242
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	5942a5a8-c3c1-4ecb-921e-9bc92393bdf8	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207743 application number: ANDA207743 ndc (product): 68382-800 ndc (product): 68382-799 ndc (product): 68382-798
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Cardinal Health 107, LLC	63db5b00-e864-4b2d-84f2-00bf35211b9b	2025-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207743 application number: ANDA207743 ndc (product): 55154-8192
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	American Health Packaging	3004aa59-288c-4971-b77b-78789715ef5a	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207743 application number: ANDA207743 ndc (product): 60687-450 ndc (product): 60687-439 ndc (product): 60687-461
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Zydus Lifesciences Limited	a3c0cc1e-1c01-4009-afdc-d35a66546aec	2024-11-30		Exact identifier application applno (ANDA): 207743 application number: ANDA207743 ndc (product): 70771-1165 ndc (product): 70771-1164 ndc (product): 70771-1163

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 57 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7109	Labetalol Hydrochloride	Labetalol Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7110	Labetalol Hydrochloride	Labetalol Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7111	Labetalol Hydrochloride	Labetalol Hydrochloride	Major Pharmaceuticals	ANDA	Current
55154-2339	Labetalol Hydrochloride	Labetalol Hydrochloride	Cardinal Health	ANDA	Current
55154-2339	Labetalol Hydrochloride	Labetalol Hydrochloride	Cardinal Health	ANDA	Current
55154-8192	Labetalol Hydrochloride	Labetalol Hydrochloride	Cardinal Health 107, LLC	ANDA	Current
55154-8192	Labetalol Hydrochloride	Labetalol Hydrochloride	Cardinal Health	ANDA	Current
60687-439	Labetalol Hydrochloride	Labetalol Hydrochloride	American Health Packaging	ANDA	Current
60687-439	Labetalol Hydrochloride	Labetalol Hydrochloride	American Health Packaging	ANDA	Current
60687-439	Labetalol Hydrochloride	Labetalol Hydrochloride	American Health Packaging	ANDA	Current
60687-450	Labetalol Hydrochloride	Labetalol Hydrochloride	American Health Packaging	ANDA	Current
60687-450	Labetalol Hydrochloride	Labetalol Hydrochloride	American Health Packaging	ANDA	Current
60687-450	Labetalol Hydrochloride	Labetalol Hydrochloride	American Health Packaging	ANDA	Current
60687-461	Labetalol Hydrochloride	Labetalol Hydrochloride	American Health Packaging	ANDA	Current
60687-461	Labetalol Hydrochloride	Labetalol Hydrochloride	American Health Packaging	ANDA	Current
60687-461	Labetalol Hydrochloride	Labetalol Hydrochloride	American Health Packaging	ANDA	Current
68001-381	Labetalol Hydrochloride	Labetalol Hydrochloride	BluePoint Laboratories Inc.	ANDA	Current
68001-381	Labetalol Hydrochloride	Labetalol Hydrochloride	BluePoint Laboratories Inc.	ANDA	Current
68001-382	Labetalol Hydrochloride	Labetalol Hydrochloride	BluePoint Laboratories Inc.	ANDA	Current
68001-382	Labetalol Hydrochloride	Labetalol Hydrochloride	BluePoint Laboratories Inc.	ANDA	Current
68001-383	Labetalol Hydrochloride	Labetalol Hydrochloride	BluePoint Laboratories Inc.	ANDA	Current
68001-383	Labetalol Hydrochloride	Labetalol Hydrochloride	BluePoint Laboratories Inc.	ANDA	Current
68382-798	Labetalol Hydrochloride	Labetalol Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-798	Labetalol Hydrochloride	Labetalol Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-798	Labetalol Hydrochloride	Labetalol Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-798	Labetalol Hydrochloride	Labetalol Hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-799	Labetalol Hydrochloride	Labetalol Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-799	Labetalol Hydrochloride	Labetalol Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-799	Labetalol Hydrochloride	Labetalol Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-799	Labetalol Hydrochloride	Labetalol Hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-800	Labetalol Hydrochloride	Labetalol Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-800	Labetalol Hydrochloride	Labetalol Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-800	Labetalol Hydrochloride	Labetalol Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-800	Labetalol Hydrochloride	Labetalol Hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70518-1132	Labetalol Hydrochloride	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1132	Labetalol Hydrochloride	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1132	Labetalol Hydrochloride	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1132	Labetalol Hydrochloride	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1132	Labetalol Hydrochloride	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1163	Labetalol Hydrochloride	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1163	Labetalol Hydrochloride	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1163	Labetalol Hydrochloride	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1163	Labetalol Hydrochloride	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70771-1163	Labetalol Hydrochloride	Labetalol Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1163	Labetalol Hydrochloride	Labetalol Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1163	Labetalol Hydrochloride	Labetalol Hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1163	Labetalol Hydrochloride	Labetalol Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1164	Labetalol Hydrochloride	Labetalol Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1164	Labetalol Hydrochloride	Labetalol Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1164	Labetalol Hydrochloride	Labetalol Hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1164	Labetalol Hydrochloride	Labetalol Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1165	Labetalol Hydrochloride	Labetalol Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1165	Labetalol Hydrochloride	Labetalol Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1165	Labetalol Hydrochloride	Labetalol Hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1165	Labetalol Hydrochloride	Labetalol Hydrochloride	Cadila Healthcare Limited	ANDA	Current
71335-1242	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1242	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current