Application 207863

Type: ANDA
Sponsor: ATHEM

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 43.

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	Approval date
A207863-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04
A207863-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04
A207863-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207863-001	AB
A207863-002	AB
A207863-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207863-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2019-02-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207863-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2019-02-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207863-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2019-02-04	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207863-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207863-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207863-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207863-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207863-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207863-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207863-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207863-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207863-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207863-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207863-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207863-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207863-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207863-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207863-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207863-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207863-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207863-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207863-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207863-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207863-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207863-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207863-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207863-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207863-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207863-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207863-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207863-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207863-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207863-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207863-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207863-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207863-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207863-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207863-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207863-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207863-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207863-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207863-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207863-001	AB	1	`301d65b070ca…`

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 2 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	REMEDYREPACK INC.	ae5d7b3b-e444-48d3-9d85-9b07319f9374	2026-04-10	Warnings, Adverse reactions	Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Advagen Pharma Ltd	106a0959-5830-489f-ba60-afd4eb0fac36	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Advagen Pharma Ltd	1c680447-b43a-4ff1-bc64-2c2174ca1c9a	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: LABETALOL HYDROCHLORIDE generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	d4364caf-46c6-4144-9ba5-2c561e4f3a95	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	3909ac9e-6818-4c5d-ad0e-52865a574b45	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	35e7bce0-d9ff-4f8b-95c5-218da2a2d929	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	f7f7fade-98a6-4741-bfb9-f1eb54ad4565	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	d207396a-068e-4229-88cc-a1a4df7aeff2	2026-03-07	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	b4a5f170-a400-4986-8c64-f55d0413f0f6	2026-03-07	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	bf84ebae-3c91-4448-b1db-8e5ed3053866	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Major Pharmaceuticals	35b5fd32-581d-427b-9a13-b7a02846d21d	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Civica, Inc.	d7c53b1c-b6a5-482a-a7c8-7425d9cd9ef8	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	5942a5a8-c3c1-4ecb-921e-9bc92393bdf8	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	ed0188ba-3fd3-4680-a829-ba242a115fab	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Biocon Pharma Inc.	27e4ab03-c17b-4268-912c-e45a5e8f8dd8	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	0db22a64-1863-4188-850b-273ea746e327	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	d8b69cc9-bdee-4e24-a3d8-d1887de5a17d	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	6f919513-500e-4a05-935e-b6fc1615368a	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Northwind Health Company, LLC	faf7a1ff-f18a-8ca7-e053-6394a90a1b1f	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Innogenix, Inc.	82fc2d64-0572-4a9b-94fc-f6eb8d930c54	2025-12-23	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
14803-502	Labetalol Hydrochloride	Labetalol Hydrochloride	ELYSIUM PHARMACEUTICALS LIMITED	ANDA	Current
14803-503	Labetalol Hydrochloride	Labetalol Hydrochloride	ELYSIUM PHARMACEUTICALS LIMITED	ANDA	Current
14803-504	Labetalol Hydrochloride	Labetalol Hydrochloride	ELYSIUM PHARMACEUTICALS LIMITED	ANDA	Current
50090-4917	Labetalol Hydrochloride	Labetalol Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4917	Labetalol Hydrochloride	Labetalol Hydrochloride	A-S Medication Solutions	ANDA	Current
63629-2053	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2053	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2054	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2054	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2055	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2055	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
70518-2728	Labetalol Hydrochloride	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2728	Labetalol Hydrochloride	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2728	Labetalol Hydrochloride	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2903	Labetalol Hydrochloride	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2903	Labetalol Hydrochloride	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-574	Labetalol Hydrochloride	Labetalol Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-751	Labetalol Hydrochloride	Labetalol Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71930-035	Labetalol Hydrochloride	Labetalol Hydrochloride	Eywa Pharma Inc	ANDA	Current
71930-035	Labetalol Hydrochloride	Labetalol Hydrochloride	Eywa Pharma Inc	ANDA	Current
71930-035	Labetalol Hydrochloride	Labetalol Hydrochloride	Eywa Pharma Inc	ANDA	Current
71930-036	Labetalol Hydrochloride	Labetalol Hydrochloride	Eywa Pharma Inc	ANDA	Current
71930-036	Labetalol Hydrochloride	Labetalol Hydrochloride	Eywa Pharma Inc	ANDA	Current
71930-036	Labetalol Hydrochloride	Labetalol Hydrochloride	Eywa Pharma Inc	ANDA	Current
71930-037	Labetalol Hydrochloride	Labetalol Hydrochloride	Eywa Pharma Inc	ANDA	Current
71930-037	Labetalol Hydrochloride	Labetalol Hydrochloride	Eywa Pharma Inc	ANDA	Current
71930-037	Labetalol Hydrochloride	Labetalol Hydrochloride	Eywa Pharma Inc	ANDA	Current