FDA.reportPublic FDA data

Application 021764

Type
NDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QOLIANABRIMONIDINE TARTRATESOLUTION/DROPS;OPHTHALMIC0.15%NoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021764-001QOLIANABRIMONIDINE TARTRATE0.15%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021764-001AT

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021764-001QOLIANA0.15%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-05-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021764-001QOLIANA0.15%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-05-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021764-001QOLIANA0.15%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-05-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021764-001QOLIANA0.15%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-05-22a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N021764-001AT1c2088c7a36db…
2026-09-14 22:38:342026-08N021764-001AT184e616aacf4f…
2026-08-18 06:07:402026-07N021764-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021764-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021764-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021764-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021764-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021764-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021764-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021764-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021764-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021764-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021764-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021764-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021764-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021764-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021764-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021764-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021764-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021764-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021764-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021764-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021764-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021764-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N021764-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021764-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021764-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021764-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N021764-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021764-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021764-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021764-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021764-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021764-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021764-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021764-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021764-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021764-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021764-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021764-001AT13a93d1ddd44b…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021764-00172651172025-08-19Drug product31067a03dcf5…
2025-08-23 18:47 UTC2025-08N021764-00172651172025-08-19Drug product6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021764-00172651172025-08-19Drug productfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021764-00172651172025-08-19Drug productb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021764-00172651172025-08-19Drug product03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021764-00172651172025-08-19Drug product2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021764-00172651172025-08-19Drug product5bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021764-00172651172025-08-19Drug productd8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021764-00172651172025-08-19Drug productd06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021764-00172651172025-08-19Drug product79d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021764-00172651172025-08-19Drug product301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021764-00172651172025-08-19Drug product1e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021764-00172651172025-08-19Drug product8072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021764-00172651172025-08-19Drug product5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021764-00172651172025-08-19Drug product5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021764-00172651172025-08-19Drug product4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021764-00172651172025-08-19Drug product74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021764-00172651172025-08-19Drug productbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021764-00172651172025-08-19Drug product782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021764-00172651172025-08-19Drug product87673890dc5c…
2021-03-12 10:30 UTC2021-03N021764-00172651172025-08-19Drug product5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021764-00172651172025-08-19Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021764-00172651172025-08-19Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021764-00172651172025-08-19Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021764-00172651172025-08-19Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021764-00172651172025-08-19Drug productea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021764-00172651172025-08-19Drug product6a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021764-00172651172025-08-19Drug product1c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021764-00172651172025-08-19Drug productea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021764-00172651172025-08-19Drug producta72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021764-00172651172025-08-19Drug product9b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021764-00172651172025-08-19Drug producta67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021764-00172651172025-08-19Drug product3f0d92c62455…
2023-05-13 08:27 UTC2023-05N021764-00172651172025-08-19Drug product053a50430f4f…
2023-01-26 05:58 UTC2023-01N021764-00172651172025-08-19Drug product3bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021764-00172651172025-08-19Drug product3a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021764-00172651172025-08-19Drug productf41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021764-00172651172025-08-19Drug producte64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021764-00172651172025-08-19Drug productcb3db0bc1861…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brimonidine TartrateBRIMONIDINE TARTRATESandoz Incb1e7ebd4-d0d2-40a5-aa11-5f68bc5972bd2025-11-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 021764
application number: NDA021764
ndc (product): 61314-144

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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61314-144Brimonidine TartrateBrimonidine TartrateSandoz IncNDACurrent
61314-144Brimonidine TartrateBrimonidine TartrateSandoz IncNDACurrent
61314-144Brimonidine TartrateBrimonidine TartrateSandoz IncNDACurrent
63629-8792Brimonidine TartrateBrimonidine TartrateBryant Ranch PrepackNDACurrent
63629-8792Brimonidine TartrateBrimonidine TartrateBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84295SUPPL 2025-11-25
84270SUPPL 2025-11-24
37607SUPPL2012-03-28
6142SUPPL2012-03-28
37606SUPPL2010-08-10
28551SUPPL2010-08-06
42303ORIG2008-02-22
28550ORIG2006-05-25
16331ORIG2006-05-24