Application 050790

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RESTASIS	CYCLOSPORINE	EMULSION;OPHTHALMIC	0.05%	Yes	Yes
002	RESTASIS MULTIDOSE	CYCLOSPORINE	EMULSION;OPHTHALMIC	0.05%	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050790-001	RESTASIS	CYCLOSPORINE	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23
N050790-002	RESTASIS MULTIDOSE	CYCLOSPORINE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050790-001	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N050790-002	8292129	2031-02-25	Drug product, Delist requested	2017-06-26
N050790-002	8561859	2032-04-16	Drug product, Delist requested	2017-06-26
N050790-002	9676525	2034-02-07	Drug product, Delist requested	2017-06-26
N050790-002	9669974	2034-05-11	Drug product, Delist requested	2017-06-26

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 3 · 82 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	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2002-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2002-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`782e0a99824c…`

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	N050790-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050790-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050790-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050790-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050790-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050790-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050790-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050790-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050790-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050790-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050790-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050790-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050790-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050790-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050790-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050790-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050790-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N050790-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050790-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050790-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050790-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050790-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050790-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050790-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050790-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050790-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050790-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050790-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050790-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050790-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050790-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050790-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 428 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	N050790-002	8292129	2031-02-25		Drug product, Delist requested	2017-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050790-002	8561859	2032-04-16		Drug product, Delist requested	2017-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050790-002	9676525	2034-02-07		Drug product, Delist requested	2017-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050790-002	9669974	2034-05-11		Drug product, Delist requested	2017-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050790-002	8292129	2031-02-25		Drug product, Delist requested	2017-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050790-002	8561859	2032-04-16		Drug product, Delist requested	2017-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050790-002	9676525	2034-02-07		Drug product, Delist requested	2017-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050790-002	9669974	2034-05-11		Drug product, Delist requested	2017-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050790-002	8292129	2031-02-25		Drug product, Delist requested	2017-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050790-002	8561859	2032-04-16		Drug product, Delist requested	2017-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050790-002	9676525	2034-02-07		Drug product, Delist requested	2017-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050790-002	9669974	2034-05-11		Drug product, Delist requested	2017-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050790-002	8292129	2031-02-25		Drug product	2017-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050790-002	8561859	2032-04-16		Drug product	2017-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050790-002	9676525	2034-02-07		Drug product	2017-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050790-002	9669974	2034-05-11		Drug product	2017-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050790-002	8292129	2031-02-25		Drug product	2017-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050790-002	8561859	2032-04-16		Drug product	2017-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050790-002	9676525	2034-02-07		Drug product	2017-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050790-002	9669974	2034-05-11		Drug product	2017-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050790-002	8629111	2024-08-27		Drug product, Delist requested	2016-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050790-002	8633162	2024-08-27	U-1479	Delist requested	2016-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050790-002	8642556	2024-08-27		Drug product, Delist requested	2016-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050790-002	8648048	2024-08-27	U-1483	Delist requested	2016-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050790-002	8685930	2024-08-27		Drug product, Delist requested	2016-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050790-002	9248191	2024-08-27	U-1479	Delist requested	2016-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050790-002	8292129	2031-02-25		Drug product	2017-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050790-002	8561859	2032-04-16		Drug product	2017-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050790-002	9676525	2034-02-07		Drug product	2017-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050790-002	9669974	2034-05-11		Drug product	2017-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050790-002	8629111	2024-08-27		Drug product, Delist requested	2016-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050790-002	8633162	2024-08-27	U-1479	Delist requested	2016-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050790-002	8642556	2024-08-27		Drug product, Delist requested	2016-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050790-002	8648048	2024-08-27	U-1483	Delist requested	2016-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050790-002	8685930	2024-08-27		Drug product, Delist requested	2016-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050790-002	9248191	2024-08-27	U-1479	Delist requested	2016-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050790-002	8292129	2031-02-25		Drug product	2017-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050790-002	8561859	2032-04-16		Drug product	2017-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050790-002	9676525	2034-02-07		Drug product	2017-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050790-002	9669974	2034-05-11		Drug product	2017-06-26	`2680178bc6a6…`

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
Restasis MultiDose	CYCLOSPORINE	Allergan, Inc.	7224d810-bb96-4682-a942-3355e6e8061a	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050790 application number: NDA050790 ndc (product): 0023-5301
Cyclosporine	CYCLOSPORINE	Apotex Corp	70c8a4a6-ebe2-457f-a626-400c338cec2d	2024-09-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050790 application number: NDA050790 ndc (product): 60505-6202
Cyclosporine	CYCLOSPORINE	KVK-TECH, INC.	a7040dc6-063b-40ee-8f2a-153e87b08430	2024-09-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050790 application number: NDA050790 ndc (product): 10702-808
RESTASIS	CYCLOSPORINE	Allergan, Inc.	8e24af2b-bc1c-4849-94f2-6df950cdca89	2024-09-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050790 application number: NDA050790 ndc (product): 0023-9163
CYCLOSPORINE	CYCLOSPORINE	Lupin Pharmaceuticals, Inc.	9aca2026-af86-4e97-925e-c202b87c46ac	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050790 application number: NDA050790 ndc (product): 68180-214
RESTASIS	CYCLOSPORINE	A-S Medication Solutions	ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050790 application number: NDA050790 ndc (product): 50090-4476

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-5301	Restasis MultiDose	cyclosporine	Allergan, Inc.	NDA	Current
0023-5301	Restasis MultiDose	cyclosporine	Allergan, Inc.	NDA	Current
0023-5301	Restasis MultiDose	cyclosporine	Allergan, Inc.	NDA	Current
0023-9163	RESTASIS	cyclosporine	Allergan, Inc.	NDA	Current
0023-9163	RESTASIS	cyclosporine	Allergan, Inc.	NDA	Current
0023-9163	RESTASIS	cyclosporine	Allergan, Inc.	NDA	Current
0023-9163	RESTASIS	cyclosporine	Allergan, Inc.	NDA	Current
0023-9163	RESTASIS	cyclosporine	Allergan, Inc.	NDA	Current
10702-808	Cyclosporine	Cyclosporine	KVK-TECH, INC.	NDA AUTHORIZED GENERIC	Current
50090-1242	RESTASIS	cyclosporine	A-S Medication Solutions	NDA	Current
50090-1242	RESTASIS	cyclosporine	A-S Medication Solutions	NDA	Current
50090-1242	RESTASIS	cyclosporine	A-S Medication Solutions	NDA	Current
50090-4476	RESTASIS	cyclosporine	A-S Medication Solutions	NDA	Current
50090-4476	RESTASIS	cyclosporine	A-S Medication Solutions	NDA	Current
50090-5977	Cyclosporine	Cyclosporine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
60505-6202	Cyclosporine	Cyclosporine	Apotex Corp	NDA AUTHORIZED GENERIC	Current
68180-214	CYCLOSPORINE	cyclosporine	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83192	SUPPL	2025-08-26
83175	SUPPL	2025-08-22
57214	SUPPL	2019-01-14
57213	SUPPL	2019-01-14
49033	SUPPL	2017-07-21
49018	SUPPL	2017-07-19
46103	SUPPL	2016-12-09
46102	SUPPL	2016-12-09
18253	SUPPL	2013-06-04
8296	SUPPL	2012-12-05
39338	SUPPL	2012-12-04
22240	SUPPL	2007-06-11
42740	ORIG	2005-04-14
30549	SUPPL	2003-10-01
8295	SUPPL	2003-10-01
18252	SUPPL	2003-09-26
8294	SUPPL	2003-09-25
30548	ORIG	2003-09-08
18251	ORIG	2003-09-08