Application 210955

Type: ANDA
Sponsor: BEXIMCO PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NADOLOL	NADOLOL	TABLET;ORAL	20MG	No	No
002	NADOLOL	NADOLOL	TABLET;ORAL	40MG	No	No
003	NADOLOL	NADOLOL	TABLET;ORAL	80MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A210955-001	NADOLOL	NADOLOL	20MG	TABLET / ORAL	AB	2018-07-23
A210955-002	NADOLOL	NADOLOL	40MG	TABLET / ORAL	AB	2018-07-23
A210955-003	NADOLOL	NADOLOL	80MG	TABLET / ORAL	AB	2018-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210955-001	AB
A210955-002	AB
A210955-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A210955-001	NADOLOL	20MG	TABLET / ORAL	AB	2018-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210955-002	NADOLOL	40MG	TABLET / ORAL	AB	2018-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210955-003	NADOLOL	80MG	TABLET / ORAL	AB	2018-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210955-001	NADOLOL	20MG	TABLET / ORAL	AB	2018-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210955-002	NADOLOL	40MG	TABLET / ORAL	AB	2018-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210955-003	NADOLOL	80MG	TABLET / ORAL	AB	2018-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210955-001	NADOLOL	20MG	TABLET / ORAL	AB	2018-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210955-002	NADOLOL	40MG	TABLET / ORAL	AB	2018-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210955-003	NADOLOL	80MG	TABLET / ORAL	AB	2018-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210955-001	NADOLOL	20MG	TABLET / ORAL	AB	2018-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210955-002	NADOLOL	40MG	TABLET / ORAL	AB	2018-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210955-003	NADOLOL	80MG	TABLET / ORAL	AB	2018-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210955-001	NADOLOL	20MG	TABLET / ORAL	AB	2018-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210955-002	NADOLOL	40MG	TABLET / ORAL	AB	2018-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210955-003	NADOLOL	80MG	TABLET / ORAL	AB	2018-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210955-001	NADOLOL	20MG	TABLET / ORAL	AB	2018-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210955-002	NADOLOL	40MG	TABLET / ORAL	AB	2018-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210955-003	NADOLOL	80MG	TABLET / ORAL	AB	2018-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210955-001	NADOLOL	20MG	TABLET / ORAL	AB	2018-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210955-002	NADOLOL	40MG	TABLET / ORAL	AB	2018-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210955-003	NADOLOL	80MG	TABLET / ORAL	AB	2018-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210955-001	NADOLOL	20MG	TABLET / ORAL	AB	2018-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210955-002	NADOLOL	40MG	TABLET / ORAL	AB	2018-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210955-003	NADOLOL	80MG	TABLET / ORAL	AB	2018-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210955-001	NADOLOL	20MG	TABLET / ORAL	AB	2018-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210955-002	NADOLOL	40MG	TABLET / ORAL	AB	2018-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210955-003	NADOLOL	80MG	TABLET / ORAL	AB	2018-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210955-001	NADOLOL	20MG	TABLET / ORAL	AB	2018-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210955-002	NADOLOL	40MG	TABLET / ORAL	AB	2018-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210955-003	NADOLOL	80MG	TABLET / ORAL	AB	2018-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210955-001	NADOLOL	20MG	TABLET / ORAL	AB	2018-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210955-002	NADOLOL	40MG	TABLET / ORAL	AB	2018-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210955-003	NADOLOL	80MG	TABLET / ORAL	AB	2018-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210955-001	NADOLOL	20MG	TABLET / ORAL	AB	2018-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210955-002	NADOLOL	40MG	TABLET / ORAL	AB	2018-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210955-003	NADOLOL	80MG	TABLET / ORAL	AB	2018-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210955-001	NADOLOL	20MG	TABLET / ORAL	AB	2018-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210955-002	NADOLOL	40MG	TABLET / ORAL	AB	2018-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210955-003	NADOLOL	80MG	TABLET / ORAL	AB	2018-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210955-001	NADOLOL	20MG	TABLET / ORAL	AB	2018-07-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210955-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210955-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210955-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210955-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210955-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210955-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210955-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210955-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210955-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210955-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210955-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210955-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210955-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210955-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210955-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210955-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210955-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210955-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210955-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210955-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210955-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210955-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210955-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210955-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210955-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210955-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210955-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210955-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210955-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210955-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210955-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210955-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210955-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210955-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210955-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210955-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210955-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210955-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210955-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210955-001	AB	1	`8072bd15b7f6…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nadolol	NADOLOL	American Health Packaging	9acc0c81-4145-43cc-b31a-7b1e3313259d	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210955 application number: ANDA210955
Nadolol	NADOLOL	Bryant Ranch Prepack	c154d99c-e4fb-41d0-8fac-e1982672e8d7	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210955 application number: ANDA210955 ndc (product): 71335-2131
Nadolol	NADOLOL	Bryant Ranch Prepack	2d126308-c58d-4950-9dcb-eaadb1a2054f	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210955 application number: ANDA210955
Nadolol	NADOLOL	Golden State Medical Supply, Inc.	33dcfdb9-1741-71e1-e063-6294a90afdff	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210955 application number: ANDA210955
Nadolol	NADOLOL	UNICHEM PHARMACEUTICALS (USA), INC.	5a8014fb-9b65-4457-bfd5-0ab7e6de330e	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210955 application number: ANDA210955 ndc (product): 76385-134 ndc (product): 76385-133 ndc (product): 76385-135
Nadolol	NADOLOL	BluePoint Laboratories	15822faf-6924-4a63-a4e1-6058b308708c	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210955 application number: ANDA210955

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-686	Nadolol	Nadolol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-686	Nadolol	Nadolol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-686	Nadolol	Nadolol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-687	Nadolol	Nadolol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-687	Nadolol	Nadolol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-687	Nadolol	Nadolol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-688	Nadolol	Nadolol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-688	Nadolol	Nadolol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-688	Nadolol	Nadolol	Marlex Pharmaceuticals Inc	ANDA	Current
71335-2131	Nadolol	Nadolol	Bryant Ranch Prepack	ANDA	Current
76385-133	Nadolol	Nadolol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-133	Nadolol	Nadolol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-134	Nadolol	Nadolol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-134	Nadolol	Nadolol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-135	Nadolol	Nadolol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-135	Nadolol	Nadolol	Bayshore Pharmaceuticals LLC	ANDA	Current