Application 018716

Type: NDA
Sponsor: CNTY LINE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRANDATE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	100MG	Yes	No
002	TRANDATE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	200MG	Yes	No
003	TRANDATE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	300MG	Yes	No
004	TRANDATE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N018716-001	TRANDATE	LABETALOL HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24
N018716-002	TRANDATE	LABETALOL HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01
N018716-003	TRANDATE	LABETALOL HYDROCHLORIDE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01
N018716-004	TRANDATE	LABETALOL HYDROCHLORIDE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018716-002	TRANDATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018716-003	TRANDATE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018716-004	TRANDATE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018716-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018716-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018716-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018716-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018716-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018716-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018716-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018716-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018716-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018716-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018716-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018716-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018716-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018716-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018716-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018716-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018716-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018716-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018716-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018716-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018716-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018716-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018716-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018716-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018716-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018716-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018716-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018716-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018716-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018716-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018716-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018716-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018716-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018716-003	AB	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018716-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018716-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018716-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018716-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018716-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018716-003	AB	1	`a67488948f0b…`

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 · 82 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 generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Advagen Pharma Ltd	106a0959-5830-489f-ba60-afd4eb0fac36	2026-04-02	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Advagen Pharma Ltd	1c680447-b43a-4ff1-bc64-2c2174ca1c9a	2026-04-02	Warnings, Adverse reactions	Name fallback 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 generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	3909ac9e-6818-4c5d-ad0e-52865a574b45	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	35e7bce0-d9ff-4f8b-95c5-218da2a2d929	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	f7f7fade-98a6-4741-bfb9-f1eb54ad4565	2026-03-25	Warnings, Adverse reactions	Name fallback 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 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 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 generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Major Pharmaceuticals	35b5fd32-581d-427b-9a13-b7a02846d21d	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Civica, Inc.	d7c53b1c-b6a5-482a-a7c8-7425d9cd9ef8	2026-03-03	Warnings, Adverse reactions	Name fallback 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 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 generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Biocon Pharma Inc.	27e4ab03-c17b-4268-912c-e45a5e8f8dd8	2026-02-19	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	0db22a64-1863-4188-850b-273ea746e327	2026-02-09	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	d8b69cc9-bdee-4e24-a3d8-d1887de5a17d	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	6f919513-500e-4a05-935e-b6fc1615368a	2026-01-29	Warnings, Adverse reactions	Name fallback 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 generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Innogenix, Inc.	82fc2d64-0572-4a9b-94fc-f6eb8d930c54	2025-12-23	Warnings, Adverse reactions	Name fallback 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 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43199-037	Labetalol Hydrochloride	labetalol hydrochloride	County Line Pharmaceuticals LLC	NDA	Current
43199-038	Labetalol Hydrochloride	labetalol hydrochloride	County Line Pharmaceuticals LLC	NDA	Current
43199-039	Labetalol Hydrochloride	labetalol hydrochloride	County Line Pharmaceuticals LLC	NDA	Current
47781-552	Labetalol Hydrochloride	labetalol hydrochloride	Alvogen Inc.	NDA	Current
47781-552	Labetalol Hydrochloride	labetalol hydrochloride	Alvogen Inc.	NDA	Current
47781-552	Labetalol Hydrochloride	labetalol hydrochloride	Alvogen Inc.	NDA	Current
47781-552	Labetalol Hydrochloride	labetalol hydrochloride	Alvogen Inc.	NDA	Current
47781-552	Labetalol Hydrochloride	labetalol hydrochloride	Alvogen Inc.	NDA	Current
47781-553	Labetalol Hydrochloride	labetalol hydrochloride	Alvogen Inc.	NDA	Current
47781-553	Labetalol Hydrochloride	labetalol hydrochloride	Alvogen Inc.	NDA	Current
47781-553	Labetalol Hydrochloride	labetalol hydrochloride	Alvogen Inc.	NDA	Current
47781-553	Labetalol Hydrochloride	labetalol hydrochloride	Alvogen Inc.	NDA	Current
47781-553	Labetalol Hydrochloride	labetalol hydrochloride	Alvogen Inc.	NDA	Current
47781-554	Labetalol Hydrochloride	labetalol hydrochloride	Alvogen Inc.	NDA	Current
47781-554	Labetalol Hydrochloride	labetalol hydrochloride	Alvogen Inc.	NDA	Current
47781-554	Labetalol Hydrochloride	labetalol hydrochloride	Alvogen Inc.	NDA	Current
47781-554	Labetalol Hydrochloride	labetalol hydrochloride	Alvogen Inc.	NDA	Current
47781-554	Labetalol Hydrochloride	labetalol hydrochloride	Alvogen Inc.	NDA	Current
50090-2428	Labetalol Hydrochloride	labetalol hydrochloride	A-S Medication Solutions	NDA	Current
50090-3584	Labetalol Hydrochloride	labetalol hydrochloride	A-S Medication Solutions	NDA	Current
50090-4149	Labetalol Hydrochloride	labetalol hydrochloride	A-S Medication Solutions	NDA	Current
50090-4149	Labetalol Hydrochloride	labetalol hydrochloride	A-S Medication Solutions	NDA	Current
60760-231	Labetalol Hydrochloride	labetalol hydrochloride	St. Mary's Medical Park Pharmacy	NDA	Current
65483-391	Trandate	labetalol hydrochloride	Prometheus Laboratories Inc.	NDA	Current
65483-392	Trandate	labetalol hydrochloride	Prometheus Laboratories Inc.	NDA	Current
65483-393	Trandate	labetalol hydrochloride	Prometheus Laboratories Inc.	NDA	Current
68071-3180	Labetalol Hydrochloride	labetalol hydrochloride	NuCare Pharmaceuticals, Inc.	NDA	Current
70518-0027	Labetalol Hydrochloride	labetalol hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1887	Labetalol Hydrochloride	labetalol hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1887	Labetalol Hydrochloride	labetalol hydrochloride	REMEDYREPACK INC.	NDA	Current
71335-0118	Labetalol Hydrochloride	labetalol hydrochloride	Bryant Ranch Prepack	NDA	Current
71335-0118	Labetalol Hydrochloride	labetalol hydrochloride	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78269	SUPPL	2024-04-26
78268	SUPPL	2024-04-26
73504	SUPPL	2023-02-15
73488	SUPPL	2023-02-14
1046	SUPPL	2010-11-30
33572	SUPPL	2010-11-22
15114	SUPPL	2003-05-29