Application 208912

Type
NDA
Sponsor
EYEPOINT PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXYCU KITDEXAMETHASONESUSPENSION;INTRAOCULAR9%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
N208912-001DEXYCU KITDEXAMETHASONE9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208912-001107996422032-05-11Drug product2021-06-11
N208912-001100289652034-05-23U-23402018-08-03
N208912-001101596832034-05-23Drug product2019-01-23
N208912-001100225022034-06-22U-23402018-08-03
N208912-001110970612039-06-23U-3418Drug product2022-09-09

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 UTC2026-02N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-0987673890dc5c…
2021-03-12 10:30 UTC2021-03N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-093f01610625f2…
2019-09-15 20:21 UTC2019-09N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09b00525d2431f…
2019-07-19 19:46 UTC2019-07N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-093f0d92c62455…
2023-05-13 08:27 UTC2023-05N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09053a50430f4f…
2023-01-26 05:58 UTC2023-01N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD, RS2018-02-09cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 6 · 224 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208912-001107996422032-05-11Drug product2021-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208912-001100289652034-05-23U-23402018-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208912-001101596832034-05-23Drug product2019-01-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208912-001100225022034-06-22U-23402018-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208912-001110970612039-06-23U-3418Drug product2022-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208912-001107996422032-05-11Drug product2021-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208912-001100289652034-05-23U-23402018-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208912-001101596832034-05-23Drug product2019-01-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208912-001100225022034-06-22U-23402018-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208912-001110970612039-06-23U-3418Drug product2022-09-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N208912-001107996422032-05-11Drug product2021-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208912-001100289652034-05-23U-23402018-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208912-001101596832034-05-23Drug product2019-01-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208912-001100225022034-06-22U-23402018-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208912-001110970612039-06-23U-3418Drug product2022-09-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208912-001107996422032-05-11Drug product2021-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208912-001100289652034-05-23U-23402018-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208912-001101596832034-05-23Drug product2019-01-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208912-001100225022034-06-22U-23402018-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208912-001110970612039-06-23U-3418Drug product2022-09-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208912-001107996422032-05-11Drug product2021-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208912-001100289652034-05-23U-23402018-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208912-001101596832034-05-23Drug product2019-01-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208912-001100225022034-06-22U-23402018-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208912-001110970612039-06-23U-3418Drug product2022-09-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208912-001107996422032-05-11Drug product2021-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208912-001100289652034-05-23U-23402018-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208912-001101596832034-05-23Drug product2019-01-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208912-001100225022034-06-22U-23402018-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208912-001110970612039-06-23U-3418Drug product2022-09-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208912-001107996422032-05-11Drug product2021-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208912-001100289652034-05-23U-23402018-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208912-001101596832034-05-23Drug product2019-01-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208912-001100225022034-06-22U-23402018-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208912-001110970612039-06-23U-3418Drug product2022-09-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208912-001107996422032-05-11Drug product2021-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208912-001100289652034-05-23U-23402018-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208912-001101596832034-05-23Drug product2019-01-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208912-001100225022034-06-22U-23402018-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208912-001110970612039-06-23U-3418Drug product2022-09-095bbf6a4d5a75…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N208912-001NP2021-02-0974a2ff9319b5…
2021-12-28 21:50 UTC2021-12N208912-001NP2021-02-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208912-001NP2021-02-0987673890dc5c…
2021-03-12 10:30 UTC2021-03N208912-001NP2021-02-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208912-001NP2021-02-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208912-001NP2021-02-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208912-001NP2021-02-093f01610625f2…
2019-09-15 20:21 UTC2019-09N208912-001NP2021-02-09b00525d2431f…
2019-07-19 19:46 UTC2019-07N208912-001NP2021-02-09ea99ee380514…

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 5 · 86 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexamethasoneDEXAMETHASONESportpharm LLCa37486b9-4323-41fc-ac7e-869d95dc95682026-07-17Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEREMEDYREPACK INC.f5c9b70b-b835-4f3b-9643-0aec50a0d3f22026-07-07Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEPangea Pharmaceuticals, LLCa41e6e26-9ebb-4b06-866e-a24af21c644c2026-06-29Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.89e1d458-7caa-430f-9c54-360889899a732026-06-12Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.736861fa-1df8-4afd-ba4a-dd7d7bffd8652026-06-12Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEPreferred Pharmaceuticals Inc79b65fd4-16a5-42e0-b041-61d7bda0a5ff2026-06-08Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEREMEDYREPACK INC.8deaaaf7-3efd-4065-b29f-e5ef038030f82026-06-01Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONECardinal Health 107, LLCbf8acfdb-8dc8-4a69-90b0-33c680c421d62026-05-15Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
dexamethasoneDEXAMETHASONECardinal Health 107, LLC5622f8d2-1893-441b-8011-fa90c8a63b0b2026-05-05Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONESportpharm LLC12d19271-867b-41ae-a6d2-7e8de36370112026-04-24Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEPangea Pharmaceuticals, LLC37607468-0331-44c0-9bb4-5c614c7b69d42026-04-19Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
dexamethasoneDEXAMETHASONEPreferred Pharmaceuticals Inc.4c619d48-8cf9-4085-8405-c8f066bce19c2026-04-01Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEPreferred Pharmaceuticals, Inc.c4d1e578-a1d2-4d5e-8426-6b2c39f0d9bd2026-04-01Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
dexamethasoneDEXAMETHASONEMajor Pharmaceuticals64b46398-9b97-45e8-b1ba-1a202d5744482026-03-26Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
OZURDEXDEXAMETHASONEAllergan, Inc.4b204f44-6e8a-4d17-803c-268f0b04679f2026-03-11Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DEXAMETHASONEDEXAMETHASONENuCare Pharmaceuticals, Inc.4a808dd5-35b7-e879-e063-6394a90a0bf72026-02-10Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEDirect_Rx0a0db8e7-8474-3d08-e063-6294a90af3f52026-02-06Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEBryant Ranch Prepacke830be9d-0a8c-4712-93c6-284c208d6f0d2026-02-05Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEBryant Ranch Prepackb3217057-5945-452c-aa99-ab696fd8b5e72026-02-04Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEPreferred Pharmaceuticals Inc.64577454-d49e-4180-99e6-8461f74b02212026-01-20Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71879-001DexycudexamethasoneEyePoint Pharmaceuticals US, IncNDACurrent
71879-001DexycudexamethasoneEyePoint Pharmaceuticals US, IncNDACurrent
71879-001DexycudexamethasoneEyePoint Pharmaceuticals US, IncNDACurrent
71879-001DexycudexamethasoneEyePoint Pharmaceuticals US, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63429SUPPL2020-06-08
63424SUPPL2020-06-05
55861ORIG2018-10-10
52548ORIG2018-02-09
52529ORIG2018-02-09