Application 214028

Type: NDA
Sponsor: ABBVIE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VUITY	PILOCARPINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	1.25%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214028-001	VUITY	PILOCARPINE HYDROCHLORIDE	1.25%	SOLUTION/DROPS / OPHTHALMIC		RLD	2021-10-28

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N214028-001	10610518	2039-04-24	U-3252	2021-11-24
N214028-001	10610518	2039-04-24	U-3561	2021-11-24
N214028-001	10610518	2039-04-24	U-3562	2021-11-24
N214028-001	11285134	2039-04-24	U-3252	2022-04-28
N214028-001	11285134	2039-04-24	U-3561	2022-04-28
N214028-001	11285134	2039-04-24	U-3562	2022-04-28

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214028-001	D-187	2026-03-28

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.

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
2026-09-14 22:38:34	2026-08	N214028-001	VUITY	1.25%	SOLUTION/DROPS / OPHTHALMIC		RLD	2021-10-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214028-001	VUITY	1.25%	SOLUTION/DROPS / OPHTHALMIC		RLD	2021-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214028-001	VUITY	1.25%	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2021-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214028-001	VUITY	1.25%	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2021-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC	AB	RLD, RS	2021-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214028-001	VUITY	1.25%	SOLUTION / OPHTHALMIC		RLD, RS	2021-10-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214028-001	VUITY	1.25%	SOLUTION/DROPS / OPHTHALMIC		RLD	2021-10-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214028-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214028-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214028-001	AB	1	`6a471c1ec25d…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 162 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214028-001	10610518	2039-04-24	U-3562	2021-11-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214028-001	10610518	2039-04-24	U-3561	2021-11-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214028-001	10610518	2039-04-24	U-3252	2021-11-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214028-001	11285134	2039-04-24	U-3561	2022-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214028-001	11285134	2039-04-24	U-3562	2022-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214028-001	11285134	2039-04-24	U-3252	2022-04-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214028-001	10610518	2039-04-24	U-3562	2021-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214028-001	10610518	2039-04-24	U-3561	2021-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214028-001	10610518	2039-04-24	U-3252	2021-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214028-001	11285134	2039-04-24	U-3561	2022-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214028-001	11285134	2039-04-24	U-3562	2022-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214028-001	11285134	2039-04-24	U-3252	2022-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214028-001	10610518	2039-04-24	U-3562	2021-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214028-001	10610518	2039-04-24	U-3561	2021-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214028-001	10610518	2039-04-24	U-3252	2021-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214028-001	11285134	2039-04-24	U-3561	2022-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214028-001	11285134	2039-04-24	U-3562	2022-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214028-001	11285134	2039-04-24	U-3252	2022-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214028-001	10610518	2039-04-24	U-3562	2021-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214028-001	10610518	2039-04-24	U-3561	2021-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214028-001	10610518	2039-04-24	U-3252	2021-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214028-001	11285134	2039-04-24	U-3561	2022-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214028-001	11285134	2039-04-24	U-3562	2022-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214028-001	11285134	2039-04-24	U-3252	2022-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214028-001	10610518	2039-04-24	U-3562	2021-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214028-001	10610518	2039-04-24	U-3561	2021-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214028-001	10610518	2039-04-24	U-3252	2021-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214028-001	11285134	2039-04-24	U-3561	2022-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214028-001	11285134	2039-04-24	U-3562	2022-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214028-001	11285134	2039-04-24	U-3252	2022-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214028-001	10610518	2039-04-24	U-3562	2021-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214028-001	10610518	2039-04-24	U-3561	2021-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214028-001	10610518	2039-04-24	U-3252	2021-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214028-001	11285134	2039-04-24	U-3561	2022-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214028-001	11285134	2039-04-24	U-3562	2022-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214028-001	11285134	2039-04-24	U-3252	2022-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214028-001	10610518	2039-04-24	U-3562	2021-11-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214028-001	10610518	2039-04-24	U-3561	2021-11-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214028-001	10610518	2039-04-24	U-3252	2021-11-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214028-001	11285134	2039-04-24	U-3561	2022-04-28	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214028-001	NP	2024-10-28	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214028-001	D-187	2026-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214028-001	NP	2024-10-28	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214028-001	D-187	2026-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214028-001	NP	2024-10-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214028-001	NP	2024-10-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214028-001	NP	2024-10-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214028-001	NP	2024-10-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214028-001	NP	2024-10-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214028-001	NP	2024-10-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214028-001	D-187	2026-03-28	`a50c72e98297…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	6272ccac-b543-404d-9938-8583bb59ed2c	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine hydrochloride	PILOCARPINE HYDROCHLORIDE	American Health Packaging	6f950741-fd3f-4bf7-83b0-f5aa9dbceb76	2026-01-23	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	AvPAK	b85547d8-fcec-323d-e053-2995a90a4e7e	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Aurobindo Pharma Limited	438cfaa3-b5f6-4d75-ac22-b0b4e07bb118	2025-10-03	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride Ophthalmic	PILOCARPINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	93e37b61-7b90-4740-b0b4-17d39d3b03f6	2025-06-02	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Qlosi	PILOCARPINE HYDROCHLORIDE	Orasis Pharmaceuticals, Inc.	4ee2a840-1203-473a-aa42-316a3ddf2fbe	2025-05-30	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Bryant Ranch Prepack	06c054af-62b4-4373-813a-9bb2e5c92316	2024-12-12	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Bryant Ranch Prepack	fb97323d-acec-4e4a-af16-efef66d969dc	2024-12-06	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Salagen	PILOCARPINE HYDROCHLORIDE	Advanz Pharma (US) Corp.	62eda83d-d043-4c7e-8fcf-75d05efbf35b	2024-12-05	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Lannett Company, Inc.	8db0db4f-55ad-46b2-af50-e71b4a763aaa	2024-10-18	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Bryant Ranch Prepack	6a73a702-c5e2-44ea-81c8-ee7e60852c41	2024-03-22	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	AMICI PHARMACEUTICALS LLC	a86a7b63-5f6a-4c10-9270-24c7b7d50437	2022-06-12	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine hydrochloride	PILOCARPINE HYDROCHLORIDE	Actavis Pharma, Inc.	610022b7-7dc9-405a-a580-104657f43bdf	2021-08-31	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	1e87a81a-7084-4436-918b-a50451534307	2021-01-03	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Sandoz Inc	53fa0b7a-f982-48a7-92c4-6f098683c1ed	2020-05-19	Warnings, Adverse reactions	Name fallback generic name: PILOCARPINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-7098	VUITY	Pilocarpine Hydrochloride	AbbVie Inc.	NDA	Current
0074-7098	VUITY	Pilocarpine Hydrochloride	AbbVie Inc.	NDA	Current
0074-7098	VUITY	Pilocarpine Hydrochloride	AbbVie Inc.	NDA	Current
0074-7098	VUITY	Pilocarpine Hydrochloride	AbbVie Inc.	NDA	Current
0074-7098	VUITY	Pilocarpine Hydrochloride	AbbVie Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73903	SUPPL	2023-04-25
73965	SUPPL	2023-04-07
73964	SUPPL	2023-04-07
73901	SUPPL	2023-03-29
71835	SUPPL	2022-08-17
71816	SUPPL	2022-08-17
71026	ORIG	2022-05-09
69165	ORIG	2021-10-29
69157	ORIG	2021-10-29