Application 202514

Type
NDA
Sponsor
OAK PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZIOPTANTAFLUPROSTSOLUTION/DROPS;OPHTHALMIC0.0015%YesYes

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
N202514-001ZIOPTANTAFLUPROST0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N202514-001AT

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N202514-001108641592029-05-28U-778Drug product2021-01-08
N202514-00199995932029-05-28Drug product2018-07-09

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 UTC2026-02N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-1087673890dc5c…
2021-03-12 10:30 UTC2021-03N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-103f01610625f2…
2019-09-15 20:21 UTC2019-09N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10b00525d2431f…
2019-07-19 19:46 UTC2019-07N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICRLD, RS2012-02-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-103f0d92c62455…
2023-05-13 08:27 UTC2023-05N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10053a50430f4f…
2023-01-26 05:58 UTC2023-01N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N202514-001ZIOPTAN0.0015%SOLUTION/DROPS / OPHTHALMICATRLD, RS2012-02-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N202514-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202514-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N202514-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202514-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202514-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202514-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202514-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202514-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202514-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202514-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202514-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202514-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202514-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202514-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202514-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202514-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202514-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202514-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N202514-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N202514-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202514-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N202514-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N202514-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202514-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202514-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N202514-001AT1b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N202514-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N202514-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N202514-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N202514-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N202514-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N202514-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N202514-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N202514-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N202514-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N202514-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N202514-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N202514-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N202514-001AT1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N202514-001AT1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 94 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N202514-001108641592029-05-28U-778Drug product2021-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202514-00199995932029-05-28Drug product2018-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202514-001108641592029-05-28U-778Drug product2021-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202514-00199995932029-05-28Drug product2018-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N202514-001108641592029-05-28U-778Drug product2021-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202514-00199995932029-05-28Drug product2018-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202514-001108641592029-05-28U-778Drug product2021-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202514-00199995932029-05-28Drug product2018-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202514-001108641592029-05-28U-778Drug product2021-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202514-00199995932029-05-28Drug product2018-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202514-001108641592029-05-28U-778Drug product2021-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202514-00199995932029-05-28Drug product2018-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202514-001108641592029-05-28U-778Drug product2021-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202514-00199995932029-05-28Drug product2018-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202514-001108641592029-05-28U-778Drug product2021-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202514-00199995932029-05-28Drug product2018-07-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202514-001108641592029-05-28U-778Drug product2021-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202514-00199995932029-05-28Drug product2018-07-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202514-001108641592029-05-28U-778Drug product2021-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N202514-00199995932029-05-28Drug product2018-07-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202514-001108641592029-05-28U-778Drug product2021-01-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202514-00199995932029-05-28Drug product2018-07-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202514-001108641592029-05-28U-778Drug product2021-01-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202514-00199995932029-05-28Drug product2018-07-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202514-001108641592029-05-28U-778Drug product2021-01-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202514-00199995932029-05-28Drug product2018-07-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202514-001108641592029-05-28U-778Drug product2021-01-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05N202514-00199995932029-05-28Drug product2018-07-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202514-00158860352022-12-18U-778Drug substance, Drug product2012-02-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202514-001108641592029-05-28U-778Drug product2021-01-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202514-00199995932029-05-28Drug product2018-07-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202514-00158860352022-12-18U-778Drug substance, Drug product2012-02-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N202514-001108641592029-05-28U-778Drug product2021-01-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N202514-00199995932029-05-28Drug product2018-07-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202514-00158860352022-12-18U-778Drug substance, Drug product2012-02-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N202514-001108641592029-05-28U-778Drug product2021-01-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N202514-00199995932029-05-28Drug product2018-07-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202514-00158860352022-12-18U-778Drug substance, Drug product2012-02-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202514-00199995932029-05-28Drug product2018-07-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N202514-00158860352022-12-18U-778Drug substance, Drug product2012-02-27bb7c543d1eb4…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZIOPTANTAFLUPROSTThea Pharma Inc.db529b54-2ac7-4020-9791-7333bbe6c90f2026-04-23Adverse reactionsExact identifier
application applno (NDA): 202514
application number: NDA202514
ndc (product): 82584-609
Tafluprost OphthalmicTAFLUPROSTPrasco Laboratories79fceaef-7d83-4f4b-8d5c-61a6c1ee63682022-06-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 202514
application number: NDA202514
ndc (product): 66993-429

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-609ZIOPTANtafluprostAkorn, Inc.NDACurrent
17478-609ZIOPTANtafluprostAkorn, Inc.NDACurrent
17478-609ZIOPTANtafluprostAkornNDACurrent
17478-609ZIOPTANtafluprostAkorn, Inc.NDACurrent
17478-609ZIOPTANtafluprostAkornNDACurrent
17478-609ZIOPTANtafluprostAkorn, Inc.NDACurrent
66993-429Tafluprost OphthalmictafluprostPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
82584-609ZIOPTANTafluprostThea Pharma Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85185SUPPL 2026-03-02
85173SUPPL 2026-02-27
10064SUPPL2015-09-22
10063SUPPL2015-09-22
40191SUPPL2015-09-08
19356SUPPL2015-09-08
19355SUPPL2013-02-26
10062SUPPL2013-02-26
22890ORIG2012-03-13
10061ORIG2012-02-14
40190ORIG2012-02-13