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 43.

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 / INTRAOCULARRLD2018-02-09

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD2018-02-0984e616aacf4f…
2026-08-18 06:07:402026-07N208912-001DEXYCU KIT9%SUSPENSION / INTRAOCULARRLD2018-02-09caaa826d4ba7…
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…

Observed Orange Book patent history#

Patent history page 1 of 6 · 234 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N208912-001107996422032-05-11Drug product2021-06-1184e616aacf4f…
2026-09-14 22:38:342026-08N208912-001100289652034-05-23U-23402018-08-0384e616aacf4f…
2026-09-14 22:38:342026-08N208912-001101596832034-05-23Drug product2019-01-2384e616aacf4f…
2026-09-14 22:38:342026-08N208912-001100225022034-06-22U-23402018-08-0384e616aacf4f…
2026-09-14 22:38:342026-08N208912-001110970612039-06-23U-3418Drug product2022-09-0984e616aacf4f…
2026-08-18 06:07:402026-07N208912-001107996422032-05-11Drug product2021-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N208912-001100289652034-05-23U-23402018-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07N208912-001101596832034-05-23Drug product2019-01-23caaa826d4ba7…
2026-08-18 06:07:402026-07N208912-001100225022034-06-22U-23402018-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07N208912-001110970612039-06-23U-3418Drug product2022-09-09caaa826d4ba7…
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…

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 2 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexamethasoneDEXAMETHASONEPreferred Pharmaceuticals Inc.64577454-d49e-4180-99e6-8461f74b02212026-01-20Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DEXAMETHASONEDEXAMETHASONEBryant Ranch Prepack075717e3-be2a-4bb3-bead-492761bfb2872026-01-09Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
HemadyDEXAMETHASONEEdenbridge Pharmaceuticals LLC.6b9cf32c-6d60-4853-bbfd-2304ffc2c1292026-01-09Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONENorthwind Health Company, LLCaa30086a-8551-413e-9cf2-6393093cfcfd2025-12-26Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEGolden State Medical Supply, Inc.a7455c92-41ce-4e87-e053-2995a90a610f2025-12-11Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DEXAMETHASONEDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.a8d6792e-757e-4dc6-adf5-0d92110754282025-12-09Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEANI Pharmaceuticals, Inc.5d9b22ca-c619-4ee3-98eb-74544d0d5cb32025-12-04Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEKesin Pharma Corporation43e2a24a-4465-5787-e063-6394a90a0b812025-11-18Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DEXAMETHASONEDEXAMETHASONEKanchan Healthcare Inc02f7bf9c-1aa3-4734-8a3e-1f49498055d72025-11-12Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEProficient Rx LP429d0d32-a1ff-481b-b4e9-c0b17b3610a12025-11-01Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLC01cfaa3e-5e30-18fa-e063-6394a90a084e2025-10-29Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DEXAMETHASONEDEXAMETHASONEAdvagen Pharma Ltd.3c1729db-8ba3-4cba-9eff-ab4ae2c061c22025-10-22Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.2ceb3a01-f5bb-4538-b5c1-cea400901d022025-10-15Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEApotex Corp.bfaa71cb-e517-8d94-f64b-8cdbf7b8fbf22025-09-17Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
dexamethasoneDEXAMETHASONEMajor Pharmaceuticals5ec5b0e6-7fa8-4afc-97a4-d185484ada8b2025-09-08Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONERising Pharma Holdings, Inc.7cf5c17c-a80b-4547-83b2-0d53e2b933f72025-09-05Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEA-S Medication Solutions16c59e9a-8e4f-4300-bbbb-bcc982c18fc82025-08-15Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONEA-S Medication Solutions89af5591-eebf-44e7-827f-ce3b123123e42025-08-15Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
DexamethasoneDEXAMETHASONENuCare Pharmaceuticals,Inc.141e16a7-1f3d-3943-e063-6294a90ac5a92025-07-30Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE
Dexamethasone IntensolDEXAMETHASONE INTENSOLHikma Pharmaceuticals USA, Inc.b15200fb-1826-472b-a907-e677a272513b2025-06-06Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE

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 · 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