FDA.reportPublic FDA data

Application 206697

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXENATIDE SYNTHETICEXENATIDE SYNTHETICINJECTABLE;SUBCUTANEOUS300MCG/1.2ML (250MCG/ML)NoYes
002EXENATIDE SYNTHETICEXENATIDE SYNTHETICINJECTABLE;SUBCUTANEOUS600MCG/2.4ML (250MCG/ML)NoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206697-001EXENATIDE SYNTHETICEXENATIDE SYNTHETIC300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRS2024-11-19
A206697-002EXENATIDE SYNTHETICEXENATIDE SYNTHETIC600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRS2024-11-19

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
2026-08-01 22:54:322026-06A206697-001EXENATIDE SYNTHETIC300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRS2024-11-19a50c72e98297…
2026-08-01 22:54:322026-06A206697-002EXENATIDE SYNTHETIC600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRS2024-11-19a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ExenatideEXENATIDEAmneal Pharmaceuticals LLCe6cb5c8f-e97f-4a6a-95a4-939fd23939492026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206697
application number: ANDA206697