Application 203828

Type: ANDA
Sponsor: INDCHEMIE HEALTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	TABLET;ORAL	EQ 2.5MG BASE	No	No
002	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	TABLET;ORAL	EQ 5MG BASE	No	No
003	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	No	No
004	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	TABLET;ORAL	EQ 20MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203828-001	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-07-29
A203828-002	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-07-29
A203828-003	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-07-29
A203828-004	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A203828-001	AB
A203828-002	AB
A203828-003	AB
A203828-004	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 5 · 164 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	A203828-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203828-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203828-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203828-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203828-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203828-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203828-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203828-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203828-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203828-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203828-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203828-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203828-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203828-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203828-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203828-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203828-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203828-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203828-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203828-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203828-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203828-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203828-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203828-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203828-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203828-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203828-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203828-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203828-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203828-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203828-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203828-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203828-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203828-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203828-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203828-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203828-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2015-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203828-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2015-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203828-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2015-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203828-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2015-07-29	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 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	A203828-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203828-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203828-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203828-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203828-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203828-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203828-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203828-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203828-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203828-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203828-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203828-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203828-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203828-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203828-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203828-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203828-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203828-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203828-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203828-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203828-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203828-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203828-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203828-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203828-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203828-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203828-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203828-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203828-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203828-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203828-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203828-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203828-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203828-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203828-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203828-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203828-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203828-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203828-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203828-004	AB	1	`d06236e962d9…`

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
Nebivolol	NEBIVOLOL	A-S Medication Solutions	f85d7b19-51d9-47d9-bd7b-13d45ad7759b	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203828 application number: ANDA203828 ndc (product): 50090-5752
Nebivolol	NEBIVOLOL	REMEDYREPACK INC.	3745fc9d-cd3f-4877-bef0-81d9a9a05786	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203828 application number: ANDA203828 ndc (product): 70518-3527
Nebivolol	NEBIVOLOL	Ascend Laboratories, LLC	fecef8fc-b66b-4133-b66f-8d6b72750622	2025-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203828 application number: ANDA203828 ndc (product): 67877-391 ndc (product): 67877-390 ndc (product): 67877-393 ndc (product): 67877-392
Nebivolol	NEBIVOLOL	American Health Packaging	5418f2b2-3e23-4e7a-b4df-36a1515c9a12	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203828 application number: ANDA203828 ndc (product): 60687-652 ndc (product): 60687-641
Nebivolol	NEBIVOLOL	A-S Medication Solutions	5953f23b-2f41-4b49-bcdb-1691f4ffa35f	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203828 application number: ANDA203828 ndc (product): 50090-5708
Nebivolol	NEBIVOLOL	A-S Medication Solutions	cdd7a3c5-d3dd-4a89-97d7-642f96eda21b	2023-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203828 application number: ANDA203828 ndc (product): 50090-5761

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5708	Nebivolol	Nebivolol	A-S Medication Solutions	ANDA	Current
50090-5752	Nebivolol	Nebivolol	A-S Medication Solutions	ANDA	Current
50090-5761	Nebivolol	Nebivolol	A-S Medication Solutions	ANDA	Current
50090-5775	Nebivolol	Nebivolol	A-S Medication Solutions	ANDA	Current
60687-641	Nebivolol	Nebivolol	American Health Packaging	ANDA	Current
60687-652	Nebivolol	Nebivolol	American Health Packaging	ANDA	Current
67877-390	Nebivolol	Nebivolol	Ascend Laboratories, LLC	ANDA	Current
67877-390	Nebivolol	Nebivolol	Ascend Laboratories, LLC	ANDA	Current
67877-390	Nebivolol	Nebivolol	Ascend Laboratories, LLC	ANDA	Current
67877-391	Nebivolol	Nebivolol	Ascend Laboratories, LLC	ANDA	Current
67877-391	Nebivolol	Nebivolol	Ascend Laboratories, LLC	ANDA	Current
67877-391	Nebivolol	Nebivolol	Ascend Laboratories, LLC	ANDA	Current
67877-392	Nebivolol	Nebivolol	Ascend Laboratories, LLC	ANDA	Current
67877-392	Nebivolol	Nebivolol	Ascend Laboratories, LLC	ANDA	Current
67877-392	Nebivolol	Nebivolol	Ascend Laboratories, LLC	ANDA	Current
67877-393	Nebivolol	Nebivolol	Ascend Laboratories, LLC	ANDA	Current
67877-393	Nebivolol	Nebivolol	Ascend Laboratories, LLC	ANDA	Current
67877-393	Nebivolol	Nebivolol	Ascend Laboratories, LLC	ANDA	Current
70518-3527	Nebivolol	Nebivolol	REMEDYREPACK INC.	ANDA	Current