Application 075223

Type: ANDA
Sponsor: APOTHECON

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	Approval date
A075223-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	1998-11-20
A075223-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	1998-11-20
A075223-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	1998-11-20

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075223-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	1998-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075223-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	1998-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075223-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	1998-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075223-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	1998-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075223-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	1998-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075223-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	1998-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075223-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	1998-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075223-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	1998-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075223-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	1998-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075223-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	1998-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075223-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	1998-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075223-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	1998-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075223-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	1998-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075223-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	1998-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075223-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	1998-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075223-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	1998-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075223-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	1998-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075223-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	1998-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075223-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	1998-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075223-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	1998-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075223-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	1998-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075223-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	1998-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075223-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	1998-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075223-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	1998-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075223-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	1998-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075223-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	1998-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075223-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	1998-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075223-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	1998-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075223-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	1998-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075223-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	1998-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075223-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	1998-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075223-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	1998-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075223-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	1998-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075223-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	1998-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075223-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	1998-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075223-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	1998-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075223-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	1998-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075223-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	1998-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075223-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	1998-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075223-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	1998-11-20	`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 5 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	Fosun Pharma USA Inc.	f18dff28-f6f5-4ecb-9797-25062e247559	2021-01-28	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Baxter Healthcare Corporation	b17a7b3a-e7a5-4987-ae85-ad970e7540c7	2020-07-24	Warnings, Adverse reactions	Name fallback brand name: Labetalol Hydrochloride generic name: LABETALOL HYDROCHLORIDE
Labetalol hydrochloride	LABETALOL HYDROCHLORIDE	Actavis Pharma, Inc.	a5b65a9b-6b8a-48a4-9c72-0e605bb309eb	2015-12-01	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30801	ORIG	1998-11-23