Application 203455

Type: ANDA
Sponsor: INVAGEN PHARMS

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	RLD / RS	Approval date
A203455-001	NADOLOL	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18
A203455-002	NADOLOL	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18
A203455-003	NADOLOL	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203455-001	AB
A203455-002	AB
A203455-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB		2015-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB		2015-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB		2015-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`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	A203455-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203455-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203455-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203455-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203455-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203455-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203455-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203455-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203455-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203455-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203455-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203455-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203455-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203455-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203455-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203455-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203455-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203455-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203455-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203455-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203455-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203455-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203455-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203455-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203455-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203455-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203455-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203455-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203455-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203455-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203455-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203455-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203455-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203455-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203455-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203455-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203455-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203455-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203455-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203455-001	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	9e8e129d-cb17-45fc-b3e2-2600c0166463	2025-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203455 application number: ANDA203455 ndc (product): 60687-302 ndc (product): 60687-313
Nadolol	NADOLOL	BluePoint Laboratories	0a2acdc0-aab6-462e-a377-67a0f3d55ec6	2024-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203455 application number: ANDA203455 ndc (product): 68001-317 ndc (product): 68001-319 ndc (product): 68001-318
Nadolol	NADOLOL	Bryant Ranch Prepack	2fc1f850-9653-4082-929a-926b644810e7	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203455 application number: ANDA203455
Nadolol	NADOLOL	Bryant Ranch Prepack	9cf4ca73-2d38-44c2-a522-d44d536b5e55	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203455 application number: ANDA203455
Nadolol	NADOLOL	Exelan Pharmaceuticals Inc.	5c6737f8-8fd8-4d8f-a66a-e99d3b64e1dd	2024-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203455 application number: ANDA203455 ndc (product): 76282-349 ndc (product): 76282-348 ndc (product): 76282-347
Nadolol	NADOLOL	Cipla USA Inc.	c899eedb-4113-45da-acc3-8e181250a7d8	2024-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203455 application number: ANDA203455 ndc (product): 69097-869 ndc (product): 69097-868 ndc (product): 69097-867

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7070	Nadolol	Nadolol	Major Pharmaceuticals	ANDA	Current
0904-7070	Nadolol	Nadolol	Major Pharmaceuticals	ANDA	Current
0904-7070	Nadolol	Nadolol	Major Pharmaceuticals	ANDA	Current
0904-7071	Nadolol	Nadolol	Major Pharmaceuticals	ANDA	Current
0904-7071	Nadolol	Nadolol	Major Pharmaceuticals	ANDA	Current
0904-7071	Nadolol	Nadolol	Major Pharmaceuticals	ANDA	Current
31722-347	Nadolol	Nadolol	Camber, Pharmaceuticals Inc	ANDA	Current
31722-348	Nadolol	Nadolol	Camber, Pharmaceuticals Inc	ANDA	Current
31722-349	Nadolol	Nadolol	Camber, Pharmaceuticals Inc	ANDA	Current
60687-302	Nadolol	Nadolol	American Health Packaging	ANDA	Current
60687-302	Nadolol	Nadolol	American Health Packaging	ANDA	Current
60687-302	Nadolol	Nadolol	American Health Packaging	ANDA	Current
60687-313	Nadolol	Nadolol	American Health Packaging	ANDA	Current
60687-313	Nadolol	Nadolol	American Health Packaging	ANDA	Current
60687-313	Nadolol	Nadolol	American Health Packaging	ANDA	Current
60687-324	Nadolol	Nadolol	American Health Packaging	ANDA	Current
67787-347	Nadolol	Nadolol	InvaGen Pharmaceuticals Inc.	ANDA	Current
67787-348	Nadolol	Nadolol	InvaGen Pharmaceuticals Inc.	ANDA	Current
67787-349	Nadolol	Nadolol	InvaGen Pharmaceuticals Inc.	ANDA	Current
68001-317	Nadolol	Nadolol	BluePoint Laboratories	ANDA	Current
68001-318	Nadolol	Nadolol	BluePoint Laboratories	ANDA	Current
68001-319	Nadolol	Nadolol	BluePoint Laboratories	ANDA	Current
69097-867	Nadolol	Nadolol	Cipla USA Inc.	ANDA	Current
69097-867	Nadolol	Nadolol	Cipla USA Inc.	ANDA	Current
69097-868	Nadolol	Nadolol	Cipla USA Inc.	ANDA	Current
69097-868	Nadolol	Nadolol	Cipla USA Inc.	ANDA	Current
69097-869	Nadolol	Nadolol	Cipla USA Inc.	ANDA	Current
69097-869	Nadolol	Nadolol	Cipla USA Inc.	ANDA	Current
70518-1755	Nadolol	Nadolol	REMEDYREPACK INC.	ANDA	Current
70518-1755	Nadolol	Nadolol	REMEDYREPACK INC.	ANDA	Current
76282-347	Nadolol	Nadolol	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-348	Nadolol	Nadolol	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-349	Nadolol	Nadolol	Exelan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10217	ORIG	2015-12-22