Home Applications 020119 Application 020119
Type NDA
Sponsor HQ SPECLT PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VUMON TENIPOSIDE INJECTABLE;INJECTION 10MG/ML Yes No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020119-001 VUMON TENIPOSIDE 10MG/ML INJECTABLE / INJECTION RLD 1992-07-14
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 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N020119-001 VUMON 10MG/ML INJECTABLE / INJECTION RLD 1992-07-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020119-001 VUMON 10MG/ML INJECTABLE / INJECTION RLD 1992-07-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020119-001 VUMON 10MG/ML INJECTABLE / INJECTION RLD 1992-07-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020119-001 VUMON 10MG/ML INJECTABLE / INJECTION RLD 1992-07-14 a50c72e98297…
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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 44567-507 Teniposide Teniposide WG Critical Care, LLC NDA Current 44567-507 Teniposide Teniposide WG Critical Care, LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 34275 SUPPL 2015-03-05 21177 SUPPL 2015-03-05 34274 SUPPL 2011-10-25 12225 SUPPL 2011-10-25 21176 SUPPL 2011-10-24 2030 SUPPL 2011-10-24 21175 SUPPL 2009-02-13 21174 SUPPL 2002-10-02