Application 022134

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LASTACAFT	ALCAFTADINE	SOLUTION/DROPS;OPHTHALMIC	0.25%	Yes	Yes

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

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
N022134-001	LASTACAFT	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2010-07-28

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12
N022134-001	8664215	2027-12-23	U-3267		2014-03-21

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022134-001	LASTACAFT	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2010-07-28	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022134-001	8664215	2027-12-23	U-1493		2014-03-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022134-001	10617695	2027-03-19	U-3267	Drug product	2020-05-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022134-001	8664215	2027-12-23	U-3267		2014-03-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022134-001	10617695	2027-03-19	U-1493	Drug product	2020-05-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022134-001	8664215	2027-12-23	U-1493		2014-03-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022134-001	10617695	2027-03-19	U-1493	Drug product	2020-05-12	`87673890dc5c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LASTACAFT	ALCAFTADINE	Allergan, Inc.	a3002410-4bf1-4182-9d7c-8193eb7cd215	2022-08-10	Warnings	Exact identifier application applno (NDA): 022134 application number: NDA022134 ndc (product): 0023-4291
LASTACAFT	ALCAFTADINE	Allergan, Inc.	17d37e8d-7825-424b-b6ca-0a85d0bf4694	2020-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022134 application number: NDA022134 ndc (product): 0023-4290

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-4290	LASTACAFT	alcaftadine	Allergan, Inc.	NDA	Current
0023-4290	LASTACAFT	alcaftadine	Allergan, Inc.	NDA	Current
0023-4290	LASTACAFT	alcaftadine	Allergan, Inc.	NDA	Current
0023-4290	LASTACAFT	alcaftadine	Allergan, Inc.	NDA	Current
0023-4290	LASTACAFT	alcaftadine	Allergan, Inc.	NDA	Current
0023-4291	LASTACAFT	alcaftadine	Allergan, Inc.	NDA	Current
0023-4291	LASTACAFT	alcaftadine	Allergan, Inc.	NDA	Current
0023-4291	LASTACAFT	alcaftadine	Allergan, Inc.	NDA	Current
42254-288	LASTACAFT	alcaftadine	Rebel Distributors Corp	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71965	SUPPL	2022-08-30
69575	SUPPL	2021-12-15
69540	SUPPL	2021-12-13
63535	SUPPL	2020-06-12
63476	SUPPL	2020-06-10
17001	SUPPL	2015-10-07
6948	SUPPL	2015-10-02
38295	SUPPL	2014-12-10
29305	SUPPL	2014-12-05
24249	ORIG	2011-02-17
21945	ORIG	2010-08-23
38294	ORIG	2010-07-31
29304	ORIG	2010-07-30
53165	ORIG	1900-01-01
53164	ORIG	1900-01-01
53163	ORIG	1900-01-01