Application 211953

Type: ANDA
Sponsor: RUBICON

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 42.

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
A211953-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18
A211953-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18
A211953-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211953-001	AB
A211953-002	AB
A211953-003	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 3 · 102 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
2026-08-18 06:07:40	2026-07	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211953-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2021-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211953-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2021-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211953-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-08-18	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211953-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211953-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211953-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211953-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211953-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211953-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211953-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211953-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211953-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211953-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211953-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211953-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211953-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211953-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211953-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211953-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211953-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211953-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211953-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211953-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211953-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211953-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211953-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211953-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211953-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211953-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211953-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211953-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211953-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211953-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211953-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211953-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211953-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211953-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211953-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211953-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211953-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211953-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211953-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211953-001	AB	1	`1e350fbaab3a…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	ed2293f8-2b82-c3db-e053-2995a90ad46c	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953 ndc (product): 60760-784
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	fffb7c59-ad92-4e74-850d-d94d42b7fdc9	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	04f9dcdf-4023-48ee-9e7d-ca9366d9db72	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953 ndc (product): 71335-2169
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	REMEDYREPACK INC.	ae5d7b3b-e444-48d3-9d85-9b07319f9374	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953 ndc (product): 70518-3499
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Advagen Pharma Ltd	106a0959-5830-489f-ba60-afd4eb0fac36	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Advagen Pharma Ltd	1c680447-b43a-4ff1-bc64-2c2174ca1c9a	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953 ndc (product): 72888-121 ndc (product): 72888-120 ndc (product): 72888-122
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	Redpharm Drug	32525ed4-3cca-2b99-e063-6294a90a6c66	2025-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	e6836a01-220d-4b69-9b4a-c919daeb6ece	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	1a71964e-e6fa-443e-bfdd-f8852f8cf29e	2023-10-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953
LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	c586ab65-56e8-4a4f-b471-902198d3e58c	2023-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211953 application number: ANDA211953

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60760-784	LABETALOL HYDROCHLORIDE	Labetalol Hydrochloride	ST. MARY'S MEDICAL PARK PHARMACY	ANDA	Current
70518-3499	LABETALOL HYDROCHLORIDE	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3499	LABETALOL HYDROCHLORIDE	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3557	LABETALOL HYDROCHLORIDE	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-2169	LABETALOL HYDROCHLORIDE	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72888-120	LABETALOL HYDROCHLORIDE	Labetalol Hydrochloride	Advagen Pharma Ltd	ANDA	Current
72888-121	LABETALOL HYDROCHLORIDE	Labetalol Hydrochloride	Advagen Pharma Ltd	ANDA	Current
72888-122	LABETALOL HYDROCHLORIDE	Labetalol Hydrochloride	Advagen Pharma Ltd	ANDA	Current