FDA.reportPublic FDA data

Application 219745

Type
NDA
Sponsor
ACCORD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAMCEVI ETMLEUPROLIDE MESYLATEEMULSION;SUBCUTANEOUSEQ 21MG BASEYesYes

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
N219745-001CAMCEVI ETMLEUPROLIDE MESYLATEEQ 21MG BASEEMULSION / SUBCUTANEOUSRLD, RS2025-08-25

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219745-001106465722027-01-16Drug product2026-06-03
N219745-00197442072027-01-16Drug product2026-06-03
N219745-00195728572029-08-02Drug product2026-06-03
N219745-001121338782037-12-18Drug product2026-06-03
N219745-001117175552039-01-01Drug product2026-06-03

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219745-001NS2028-08-25

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 06:07:402026-07N219745-001CAMCEVI ETMEQ 21MG BASEEMULSION / SUBCUTANEOUSRLD, RS2025-08-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219745-001CAMCEVI ETMEQ 21MG BASEEMULSION / SUBCUTANEOUSRLD, RS2025-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219745-001CAMCEVI ETMEQ 21MG BASEEMULSION / SUBCUTANEOUSRLD, RS2025-08-2531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219745-001CAMCEVI ETMEQ 21MG BASEEMULSION / SUBCUTANEOUSRLD, RS2025-08-25a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N219745-001106465722027-01-16Drug product2026-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219745-00197442072027-01-16Drug product2026-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219745-00195728572029-08-02Drug product2026-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219745-001121338782037-12-18Drug product2026-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219745-001117175552039-01-01Drug product2026-06-03caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219745-001106465722027-01-16Drug product2026-06-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219745-00197442072027-01-16Drug product2026-06-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219745-00195728572029-08-02Drug product2026-06-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219745-001121338782037-12-18Drug product2026-06-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219745-001117175552039-01-01Drug product2026-06-03a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N219745-001NS2028-08-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219745-001NS2028-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219745-001NS2028-08-2531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219745-001NS2028-08-25a50c72e98297…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83212ORIG 2025-08-27
83203ORIG 2025-08-26