Application 018385

Type
NDA
Sponsor
NOVO NORDISK INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ULTRALENTEINSULIN ZINC SUSP EXTENDED PURIFIED BEEFINJECTABLE;INJECTION100 UNITS/MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

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
2019-12-13 00:20 UTC2019-12N018385-001ULTRALENTE100 UNITS/MLINJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2019-12-14 00:12 UTC2019-12N018385-001ULTRALENTE100 UNITS/MLINJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N018385-001ULTRALENTE100 UNITS/MLINJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N018385-001ULTRALENTE100 UNITS/MLINJECTABLE / INJECTIONApproved before 1982ea99ee380514…