Application 021398

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COMBIGANBRIMONIDINE TARTRATE; TIMOLOL MALEATESOLUTION/DROPS;OPHTHALMIC0.2%;EQ 0.5% BASEYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021398-001COMBIGANBRIMONIDINE TARTRATE; TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021398-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-3087673890dc5c…
2021-03-12 10:30 UTC2021-03N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-303f01610625f2…
2019-09-15 20:21 UTC2019-09N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-30b00525d2431f…
2019-07-19 19:46 UTC2019-07N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-303f0d92c62455…
2023-05-13 08:27 UTC2023-05N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30053a50430f4f…
2023-01-26 05:58 UTC2023-01N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021398-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021398-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021398-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021398-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021398-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021398-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021398-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021398-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021398-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021398-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021398-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021398-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021398-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021398-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021398-001AB15d02ea3f76ae…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021398-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021398-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021398-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021398-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021398-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021398-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021398-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021398-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021398-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021398-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021398-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021398-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021398-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021398-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 5 · 188 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00170301492022-04-19U-8495c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00173209762022-04-19U-8495c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00176422582022-04-19U-1024Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00181338902022-04-19U-12352012-04-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00183544092022-04-19U-1371Drug product2013-03-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00187484252022-04-19U-1524Drug product2014-07-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00194747512022-04-19U-1524Drug product2016-10-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00197704532022-04-19U-2131Drug product2017-10-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00199078012022-04-19U-2239Drug product2018-03-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00199078022022-04-19U-2240Drug product2018-03-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021398-00170301492022-04-19U-8495d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00173209762022-04-19U-8495d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00176422582022-04-19U-1024Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00181338902022-04-19U-12352012-04-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00183544092022-04-19U-1371Drug product2013-03-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00187484252022-04-19U-1524Drug product2014-07-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00194747512022-04-19U-1524Drug product2016-10-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00197704532022-04-19U-2131Drug product2017-10-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00199078012022-04-19U-2239Drug product2018-03-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00199078022022-04-19U-2240Drug product2018-03-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00173234632023-01-19Drug product, Delist requested5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021398-00170301492022-04-19U-8494b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00173209762022-04-19U-8494b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00176422582022-04-19U-1024Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00181338902022-04-19U-12352012-04-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00183544092022-04-19U-1371Drug product2013-03-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00187484252022-04-19U-1524Drug product2014-07-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00194747512022-04-19U-1524Drug product2016-10-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00197704532022-04-19U-2131Drug product2017-10-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00199078012022-04-19U-2239Drug product2018-03-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00199078022022-04-19U-2240Drug product2018-03-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00173234632023-01-19Drug product, Delist requested4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021398-00170301492022-04-19U-84974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021398-00173209762022-04-19U-84974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021398-00176422582022-04-19U-1024Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021398-00181338902022-04-19U-12352012-04-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021398-00183544092022-04-19U-1371Drug product2013-03-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021398-00187484252022-04-19U-1524Drug product2014-07-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021398-00194747512022-04-19U-1524Drug product2016-10-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021398-00197704532022-04-19U-2131Drug product2017-10-1274a2ff9319b5…

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
COMBIGANBRIMONIDINE TARTRATE, TIMOLOL MALEATEAllergan, Inc.feaf1480-a4b8-4486-992a-96be3a5962432026-03-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 021398
application number: NDA021398
ndc (product): 0023-9211

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-9211COMBIGANbrimonidine tartrate, timolol maleateAllergan, Inc.NDACurrent
0023-9211COMBIGANbrimonidine tartrate, timolol maleateAllergan, Inc.NDACurrent
0023-9211COMBIGANbrimonidine tartrate, timolol maleateAllergan, Inc.NDACurrent
0023-9211COMBIGANbrimonidine tartrate, timolol maleateAllergan, Inc.NDACurrent
0023-9211COMBIGANbrimonidine tartrate, timolol maleateAllergan, Inc.NDACurrent
0023-9211COMBIGANbrimonidine tartrate, timolol maleateAllergan, Inc.NDACurrent
60505-6225Brimonidine Tartrate/Timolol Maleatebrimonidine tartrate, timolol maleateApotex CorpNDA AUTHORIZED GENERICCurrent
60505-6225Brimonidine Tartrate/Timolol Maleatebrimonidine tartrate, timolol maleateApotex CorpNDACurrent
82182-455BRIMONIDINE TARTRATE and TIMOLOL MALEATEBRIMONIDINE TARTRATE, TIMOLOL MALEATEPacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85471SUPPL 2026-03-24
85394SUPPL 2026-03-19
36817SUPPL2015-10-22
27666SUPPL2015-10-16
5249SUPPL2012-10-15
15361SUPPL2012-10-12
24196ORIG2008-07-22
42137ORIG2008-04-22
27665ORIG2007-11-08
53203ORIG1900-01-01
53202ORIG1900-01-01
53201ORIG1900-01-01