FDA.reportPublic FDA data

Application 208997

Type
ANDA
Sponsor
NOVAST LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VINORELBINE TARTRATEVINORELBINE TARTRATEINJECTABLE;INJECTIONEQ 10MG BASE/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A208997-001VINORELBINE TARTRATEVINORELBINE TARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2019-08-05

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A208997-001VINORELBINE TARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2019-08-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208997-001VINORELBINE TARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2019-08-05cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208997-001VINORELBINE TARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2019-08-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A208997-001AP1b00525d2431f…

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-420VinorelbineVinorelbineIngenus Pharmaceuticals, LLCANDACurrent
50742-420VinorelbineVinorelbineIngenus Pharmaceuticals, LLCANDACurrent
50742-420VinorelbineVinorelbineIngenus Pharmaceuticals, LLCANDACurrent
50742-427VinorelbineVinorelbineIngenus Pharmaceuticals, LLCANDACurrent
50742-427VinorelbineVinorelbineIngenus Pharmaceuticals, LLCANDACurrent
50742-427VinorelbineVinorelbineIngenus Pharmaceuticals, LLCANDACurrent