Home Applications 019557 Application 019557
Type NDA
Sponsor DAVA PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VEPESID ETOPOSIDE CAPSULE;ORAL 50MG Yes No 002 VEPESID ETOPOSIDE CAPSULE;ORAL 100MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019557-001 VEPESID ETOPOSIDE 50MG CAPSULE / ORAL AB RLD 1986-12-30 N019557-002 VEPESID ETOPOSIDE 100MG CAPSULE / ORAL RLD 1986-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019557-001 AB
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 3 · 88 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 2019-12-13 00:20 UTC 2019-12 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 3a93d1ddd44b…
Observed Orange Book normalized TE history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VePesid ETOPOSIDE Amneal Pharmaceuticals NY LLC 2a40f3ed-4a36-4616-af6c-b616140fd5ee 2026-05-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019557 application number: NDA019557
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 11529 SUPPL 2012-08-03 40936 SUPPL 2007-07-06 17453 SUPPL 2002-11-05 20261 SUPPL 1999-04-02