Application 204708

Type: NDA
Sponsor: GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIRVASO	BRIMONIDINE TARTRATE	GEL;TOPICAL	EQ 0.33% BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N204708-001	MIRVASO	BRIMONIDINE TARTRATE	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204708-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204708-001	8513247	2031-03-25	U-1428	Drug product	2013-09-13
N204708-001	8513249	2031-03-25	U-1428	Drug product	2013-09-13
N204708-001	9861631	2031-03-25	U-1428		2018-01-25
N204708-001	9861632	2031-03-25	U-1428		2018-01-25
N204708-001	10201517	2031-06-13		Drug product	2019-02-13
N204708-001	8053427	2031-06-13	U-1428	Drug product	2013-09-13
N204708-001	8163725	2031-06-13		Drug product	2013-09-13

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 · 44 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
2026-10-15 13:18:30	2026-09	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL		RLD, RS	2013-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL		RLD, RS	2013-08-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL		RLD, RS	2013-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL		RLD, RS	2013-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL		RLD, RS	2013-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL		RLD, RS	2013-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL		RLD, RS	2013-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL		RLD, RS	2013-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL		RLD, RS	2013-08-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL	AB	RLD, RS	2013-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204708-001	MIRVASO	EQ 0.33% BASE	GEL / TOPICAL		RLD, RS	2013-08-23	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N204708-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N204708-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204708-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204708-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204708-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204708-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204708-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204708-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204708-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204708-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204708-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204708-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204708-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204708-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204708-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204708-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204708-001	AB	1	`8072bd15b7f6…`
2022-04-08 23:34 UTC	2022-04	N204708-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204708-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N204708-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204708-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204708-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204708-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204708-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204708-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204708-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204708-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204708-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204708-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204708-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204708-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 499 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N204708-001	8513247	2031-03-25	U-1428	Drug product	2013-09-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204708-001	8513249	2031-03-25	U-1428	Drug product	2013-09-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204708-001	9861631	2031-03-25	U-1428		2018-01-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204708-001	9861632	2031-03-25	U-1428		2018-01-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204708-001	10201517	2031-06-13		Drug product	2019-02-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204708-001	8053427	2031-06-13	U-1428	Drug product	2013-09-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204708-001	8163725	2031-06-13		Drug product	2013-09-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N204708-001	8513247	2031-03-25	U-1428	Drug product	2013-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204708-001	8513249	2031-03-25	U-1428	Drug product	2013-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204708-001	9861631	2031-03-25	U-1428		2018-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204708-001	9861632	2031-03-25	U-1428		2018-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204708-001	10201517	2031-06-13		Drug product	2019-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204708-001	8053427	2031-06-13	U-1428	Drug product	2013-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204708-001	8163725	2031-06-13		Drug product	2013-09-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204708-001	8513247	2031-03-25	U-1428	Drug product	2013-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204708-001	8513249	2031-03-25	U-1428	Drug product	2013-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204708-001	9861631	2031-03-25	U-1428		2018-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204708-001	9861632	2031-03-25	U-1428		2018-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204708-001	10201517	2031-06-13		Drug product	2019-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204708-001	8053427	2031-06-13	U-1428	Drug product	2013-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204708-001	8163725	2031-06-13		Drug product	2013-09-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204708-001	8513247	2031-03-25	U-1428	Drug product	2013-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204708-001	8513249	2031-03-25	U-1428	Drug product	2013-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204708-001	9861631	2031-03-25	U-1428		2018-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204708-001	9861632	2031-03-25	U-1428		2018-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204708-001	10201517	2031-06-13		Drug product	2019-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204708-001	8053427	2031-06-13	U-1428	Drug product	2013-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204708-001	8163725	2031-06-13		Drug product	2013-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204708-001	8231885	2025-05-24		Drug product	2013-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204708-001	8410102	2025-05-24	U-1428		2013-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204708-001	8426410	2025-05-24	U-1428		2013-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204708-001	7439241	2025-08-25	U-1428		2013-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204708-001	8513247	2031-03-25	U-1428	Drug product	2013-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204708-001	8513249	2031-03-25	U-1428	Drug product	2013-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204708-001	9861631	2031-03-25	U-1428		2018-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204708-001	9861632	2031-03-25	U-1428		2018-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204708-001	10201517	2031-06-13		Drug product	2019-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204708-001	8053427	2031-06-13	U-1428	Drug product	2013-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204708-001	8163725	2031-06-13		Drug product	2013-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204708-001	8231885	2025-05-24		Drug product	2013-09-13	`6a471c1ec25d…`

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Apotex Corp.	e08a915a-77ca-4d16-d760-11b05848418d	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
brimonidine tartrate	BRIMONIDINE TARTRATE	Micro Labs Limited	981a75cd-2487-40e4-911a-26de2aa98dc1	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
LUMIFY Redness Reliever Eye Drops	BRIMONIDINE TARTRATE	Bausch & Lomb Incorporated	022de945-0b26-40ae-8e88-d3fe2464d106	2026-03-31	Warnings	Name fallback generic name: BRIMONIDINE TARTRATE
LUMIFY PRESERVATIVE FREE EYE DROPS	BRIMONIDINE TARTRATE	Bausch & Lomb Incorporated	ef5974b9-946c-4983-80e3-32b3aa28c207	2026-03-17	Warnings	Name fallback generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Gland Pharma Limited	e4b04ef1-6586-4386-a844-2c5fc3bd4a8f	2026-03-12	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Florida Pharmaceutical Products, LLC	a25f7abf-e066-4d16-a0ba-6150bdace81d	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Sandoz Inc	b1e7ebd4-d0d2-40a5-aa11-5f68bc5972bd	2025-11-24	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
Brimonidine	BRIMONIDINE TARTRATE	Sandoz Inc	87c5a534-4321-46c7-9938-84dca34b6506	2025-10-07	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
ALPHAGAN P	BRIMONIDINE TARTRATE	Allergan, Inc.	264c4494-c225-486f-888a-caaf36be46b3	2025-09-18	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
Brimonidine tartrate	BRIMONIDINE TARTRATE	Micro Labs Limited	75c5f708-1afb-4505-94a6-a2c0afb0aedc	2025-07-24	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Sandoz Inc	dfd85672-fa4b-40e3-ac9c-81b8d9e4ffde	2025-05-30	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	Somerset Therapeutics, LLC	cdb8620f-adfa-4433-b285-9c42334f8600	2025-03-22	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	Somerset Therapeutics, LLC	b8e108b3-aca8-4e3e-8577-37ac796148c3	2024-08-26	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Bausch & Lomb Incorporated	865f88b0-b13e-4607-a314-939f1b331e6f	2024-07-19	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Alembic Pharmaceuticals Limited	ee26e0c9-a169-4842-ab0f-3c718bb14018	2023-08-28	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Alembic Pharmaceuticals Inc.	9da815fb-6454-4925-9150-bec40eff9c2d	2023-08-11	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Indoco Remedies Limited	383421a5-5d33-4f15-88f4-8b66fcbfac71	2018-12-27	Warnings, Adverse reactions	Name fallback generic name: BRIMONIDINE TARTRATE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0299-5980	Mirvaso	brimonidine tartrate	Galderma Laboratories, L.P.	NDA	Current
0299-5980	Mirvaso	brimonidine tartrate	Galderma Laboratories, L.P.	NDA	Current
0299-5980	Mirvaso	brimonidine tartrate	Galderma Laboratories, L.P.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
19589	SUPPL	2016-07-28
10383	SUPPL	2016-07-28
40415	SUPPL	2015-10-27
44907	ORIG	2014-03-14
43474	ORIG	2014-03-14
19588	ORIG	2013-08-27
10382	ORIG	2013-08-27