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TRANDATE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N018716-001	TRANDATE	LABETALOL HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24
N018716-002	TRANDATE	LABETALOL HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01
N018716-003	TRANDATE	LABETALOL HYDROCHLORIDE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01
N018716-004	TRANDATE	LABETALOL HYDROCHLORIDE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-01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N018716-001	TRANDATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-24	`84e616aacf4f…`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 3 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	Method Pharmaceuticals, LLC	733d6e32-ac90-4796-bf25-9d5887c897a5	2025-12-23	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	99a715a0-4579-410c-b102-7ef6fab8db55	2025-12-19	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Redpharm Drug	32525ed4-3cca-2b99-e063-6294a90a6c66	2025-12-13	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Chartwell RX, LLC	ac439c08-1e47-4306-8308-b31d7a1a443c	2025-12-02	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Mullan Pharmaceutical Inc.	fb5ef3ba-0a7e-4f41-9547-d734983da0d3	2025-12-01	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	e6836a01-220d-4b69-9b4a-c919daeb6ece	2025-11-20	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	0dcd514d-bda8-484b-8cf1-f5656aaab9ce	2025-10-29	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	20c26652-52da-4eef-8486-f91eb30e9ff7	2025-10-29	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	dafa7411-2857-4f5a-a587-4367cfbe2bfa	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	dbf1e4c7-7c0c-4f2f-8cad-96bc6b800cfc	2025-10-06	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Macleods Pharmaceuticals Limited	366134cd-6244-45fc-99f1-0193a0221b3a	2025-10-06	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	RedPharm Drug	1e1b7355-4802-d277-e063-6394a90aef44	2025-07-29	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	NuCare Pharmaceuticals , Inc.	3aff731f-1eec-19b5-e063-6294a90a3143	2025-07-28	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol HCL	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	312dde0d-5147-483e-968f-4e0d46114176	2025-06-19	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Caplin Steriles Limited	77152699-1ca8-442a-8cb4-80b0ffbec6f2	2025-02-14	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	5faacbcc-f88f-42f7-8702-791ee82c4d18	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	American Health Packaging	3004aa59-288c-4971-b77b-78789715ef5a	2024-12-30	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Zydus Lifesciences Limited	a3c0cc1e-1c01-4009-afdc-d35a66546aec	2024-11-30		Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	64cd636d-8b48-4f29-b41d-4a048335793e	2024-11-20	Warnings, Adverse reactions	Name fallback generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	5b059ef2-dec0-4cea-b8df-d87df3fea9e2	2024-09-06	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