Home Applications 204708 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 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 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 · 41 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 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…2022-10-28 04:53 UTC 2022-10 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 12 · 478 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 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…2025-08-23 18:47 UTC 2025-08 N204708-001 8410102 2025-05-24 U-1428 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 8426410 2025-05-24 U-1428 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 7439241 2025-08-25 U-1428 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 8513247 2031-03-25 U-1428 Drug product 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 8513249 2031-03-25 U-1428 Drug product 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 9861631 2031-03-25 U-1428 2018-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 9861632 2031-03-25 U-1428 2018-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 10201517 2031-06-13 Drug product 2019-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 8053427 2031-06-13 U-1428 Drug product 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 8163725 2031-06-13 Drug product 2013-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 8231885 2025-05-24 Drug product 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 8410102 2025-05-24 U-1428 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 8426410 2025-05-24 U-1428 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 7439241 2025-08-25 U-1428 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 8513247 2031-03-25 U-1428 Drug product 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 8513249 2031-03-25 U-1428 Drug product 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 9861631 2031-03-25 U-1428 2018-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 9861632 2031-03-25 U-1428 2018-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 10201517 2031-06-13 Drug product 2019-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 8053427 2031-06-13 U-1428 Drug product 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 8163725 2031-06-13 Drug product 2013-09-13 fd3edfee7708…
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 Mirvaso BRIMONIDINE TARTRATE Galderma Laboratories, L.P. f6a4353f-ae69-4214-901f-e5d42a6fbde7 2024-10-24 Warnings, Adverse reactions Exact identifier application applno (NDA): 204708 application number: NDA204708 ndc (product): 0299-5980
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