FDA.reportPublic FDA data

Application 218643

Type
NDA
Sponsor
THEA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYKLXARTICAINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 8% BASEYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N218643-001CYKLXARTICAINE HYDROCHLORIDEEQ 8% BASESOLUTION/DROPS / OPHTHALMICRLD2025-08-15

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218643-001110969222039-03-27U-4423Drug product2026-03-09
N218643-001118263472039-03-27U-4423Drug product2026-03-09
N218643-001124031262039-03-27U-4422Drug product2026-03-09

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218643-001NP2028-08-15

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N218643-001CYKLXEQ 8% BASESOLUTION/DROPS / OPHTHALMICRLD2025-08-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218643-001CYKLXEQ 8% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2025-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218643-001CYKLXEQ 8% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2025-08-1531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218643-001CYKLXEQ 8% BASESOLUTION/DROPS / OPHTHALMICRLD2025-08-15a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N218643-001110969222039-03-27U-4423Drug product2026-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N218643-001118263472039-03-27U-4423Drug product2026-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N218643-001124031262039-03-27U-4422Drug product2026-03-09caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218643-001110969222039-03-27U-4423Drug product2026-03-09a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218643-001118263472039-03-27U-4423Drug product2026-03-09a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218643-001124031262039-03-27U-4422Drug product2026-03-09a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N218643-001NP2028-08-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218643-001NP2028-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218643-001NP2028-08-1531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218643-001NP2028-08-15a50c72e98297…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83802ORIG 2025-10-20
83119ORIG 2025-08-18
83116ORIG 2025-08-18