Application 212719

Type: ANDA
Sponsor: UNICHEM

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 44.

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
A212719-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-08-08
A212719-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-08-08
A212719-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2022-08-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212719-001	AB
A212719-002	AB
A212719-003	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 2 of 3 · 90 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL		2022-08-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL		2022-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL		2022-08-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL		2022-08-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL		2022-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL		2022-08-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL		2022-08-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL		2022-08-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL		2022-08-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL		2022-08-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL		2022-08-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL		2022-08-08	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL		2022-08-08	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL		2022-08-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL		2022-08-08	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL		2022-08-08	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL		2022-08-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL		2022-08-08	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL		2022-08-08	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL		2022-08-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL		2022-08-08	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL		2022-08-08	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL		2022-08-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL		2022-08-08	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL		2022-08-08	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL		2022-08-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL		2022-08-08	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL		2022-08-08	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL		2022-08-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL		2022-08-08	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL		2022-08-08	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL		2022-08-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL		2022-08-08	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL		2022-08-08	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL		2022-08-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL		2022-08-08	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL		2022-08-08	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A212719-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL		2022-08-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212719-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-08-08	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212719-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-08-08	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A212719-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A212719-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A212719-003	AB	1	`c2088c7a36db…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212719-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212719-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212719-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212719-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A212719-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A212719-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212719-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A212719-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A212719-003	AB	1	`e64feba35796…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	ed0188ba-3fd3-4680-a829-ba242a115fab	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212719 application number: ANDA212719 ndc (product): 29300-253 ndc (product): 29300-254 ndc (product): 29300-252

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-252	Labetalol Hydrochloride	Labetalol Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-253	Labetalol Hydrochloride	Labetalol Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-254	Labetalol Hydrochloride	Labetalol Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current