Application 021742

Type: NDA
Sponsor: ALLERGAN

Application Products#

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

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	RLD / RS	Approval date
N021742-002	BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17
N021742-003	BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17
N021742-004	BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17
N021742-005	BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021742-002	AB
N021742-003	AB
N021742-004	AB
N021742-005	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	N021742-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021742-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021742-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021742-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021742-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021742-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021742-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021742-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021742-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021742-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021742-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021742-005	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021742-002	6545040	2021-12-17	U-3	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021742-003	6545040	2021-12-17	U-3	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021742-004	6545040	2021-12-17	U-3	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021742-005	6545040	2021-12-17	U-3	Drug product	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021742-002	6545040	2021-12-17	U-3	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021742-003	6545040	2021-12-17	U-3	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021742-004	6545040	2021-12-17	U-3	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021742-005	6545040	2021-12-17	U-3	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021742-002	6545040	2021-12-17	U-3	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021742-003	6545040	2021-12-17	U-3	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021742-004	6545040	2021-12-17	U-3	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021742-005	6545040	2021-12-17	U-3	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021742-002	6545040	2021-12-17	U-3	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021742-003	6545040	2021-12-17	U-3	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021742-004	6545040	2021-12-17	U-3	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021742-005	6545040	2021-12-17	U-3	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021742-002	6545040	2021-12-17	U-3	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021742-003	6545040	2021-12-17	U-3	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021742-004	6545040	2021-12-17	U-3	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021742-005	6545040	2021-12-17	U-3	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021742-002	6545040	2021-12-17	U-3	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021742-003	6545040	2021-12-17	U-3	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021742-004	6545040	2021-12-17	U-3	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021742-005	6545040	2021-12-17	U-3	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021742-002	6545040	2021-12-17	U-3	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021742-003	6545040	2021-12-17	U-3	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021742-004	6545040	2021-12-17	U-3	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021742-005	6545040	2021-12-17	U-3	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021742-002	6545040	2021-12-17	U-3	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021742-003	6545040	2021-12-17	U-3	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021742-004	6545040	2021-12-17	U-3	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021742-005	6545040	2021-12-17	U-3	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021742-002	6545040	2021-12-17	U-3	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021742-003	6545040	2021-12-17	U-3	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021742-004	6545040	2021-12-17	U-3	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021742-005	6545040	2021-12-17	U-3	Drug product	`ea99ee380514…`

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
Bystolic	NEBIVOLOL HYDROCHLORIDE	Allergan, Inc.	8b8ad213-1dc8-454e-a524-075685c0e1a8	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021742 application number: NDA021742 ndc (product): 0456-1402 ndc (product): 0456-1420 ndc (product): 0456-1410 ndc (product): 0456-1405

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 52 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0456-1402	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1402	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1402	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1402	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1402	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1402	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1405	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1405	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1405	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1405	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1405	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1405	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1410	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1410	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1410	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1410	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1410	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1410	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1420	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1420	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1420	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1420	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1420	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
0456-1420	Bystolic	nebivolol hydrochloride	Allergan, Inc.	NDA	Current
50090-1127	Bystolic	nebivolol hydrochloride	A-S Medication Solutions	NDA	Current
50090-1127	Bystolic	nebivolol hydrochloride	A-S Medication Solutions	NDA	Current
50090-1307	Bystolic	nebivolol hydrochloride	A-S Medication Solutions	NDA	Current
50090-1307	Bystolic	nebivolol hydrochloride	A-S Medication Solutions	NDA	Current
50090-1307	Bystolic	nebivolol hydrochloride	A-S Medication Solutions	NDA	Current
50090-1307	Bystolic	nebivolol hydrochloride	A-S Medication Solutions	NDA	Current
50090-3326	Bystolic	nebivolol hydrochloride	A-S Medication Solutions	NDA	Current
50090-3326	Bystolic	nebivolol hydrochloride	A-S Medication Solutions	NDA	Current
50090-3326	Bystolic	nebivolol hydrochloride	A-S Medication Solutions	NDA	Current
55154-4621	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4621	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4621	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4621	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4621	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4621	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4622	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4622	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4622	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4622	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4622	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4622	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4623	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4623	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4623	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4623	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4623	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
55154-4623	Bystolic	nebivolol hydrochloride	Cardinal Health	NDA	Current
68151-5135	Bystolic	nebivolol hydrochloride	Carilion Materials Management	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74549	SUPPL	2023-06-20
74543	SUPPL	2023-06-20
50574	SUPPL	2017-12-01
50547	SUPPL	2017-12-01
28498	SUPPL	2011-12-15
16286	SUPPL	2011-12-14
16285	SUPPL	2010-03-03
6091	SUPPL	2010-02-26
42293	ORIG	2008-05-02
6090	ORIG	2008-01-09