Home Applications 202497 Application 202497
Type NDA
Sponsor ACROTECH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MARQIBO KIT VINCRISTINE SULFATE INJECTABLE, LIPOSOMAL;INTRAVENOUS 5MG/5ML (1MG/ML) Yes Yes
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 N202497-001 MARQIBO KIT VINCRISTINE SULFATE 5MG/5ML (1MG/ML) INJECTABLE, LIPOSOMAL / INTRAVENOUS RLD 2012-08-09
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 N202497-001 MARQIBO KIT 5MG/5ML (1MG/ML) INJECTABLE, LIPOSOMAL / INTRAVENOUS RLD 2012-08-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202497-001 MARQIBO KIT 5MG/5ML (1MG/ML) INJECTABLE, LIPOSOMAL / INTRAVENOUS RLD 2012-08-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202497-001 MARQIBO KIT 5MG/5ML (1MG/ML) INJECTABLE, LIPOSOMAL / INTRAVENOUS RLD 2012-08-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N202497-001 MARQIBO KIT 5MG/5ML (1MG/ML) INJECTABLE, LIPOSOMAL / INTRAVENOUS RLD 2012-08-09 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N202497-001 6723338 2020-03-31 U-1271 2012-09-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202497-001 7887836 2020-03-31 U-1271 2012-09-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202497-001 7247316 2020-09-25 Drug product 2012-09-06 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N202497-001 6723338 2020-03-31 U-1271 2012-09-06 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202497-001 7887836 2020-03-31 U-1271 2012-09-06 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202497-001 7247316 2020-09-25 Drug product 2012-09-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202497-001 6723338 2020-03-31 U-1271 2012-09-06 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202497-001 7887836 2020-03-31 U-1271 2012-09-06 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202497-001 7247316 2020-09-25 Drug product 2012-09-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202497-001 6723338 2020-03-31 U-1271 2012-09-06 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N202497-001 7887836 2020-03-31 U-1271 2012-09-06 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N202497-001 7247316 2020-09-25 Drug product 2012-09-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202497-001 6723338 2020-03-31 U-1271 2012-09-06 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N202497-001 7887836 2020-03-31 U-1271 2012-09-06 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N202497-001 7247316 2020-09-25 Drug product 2012-09-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202497-001 6723338 2020-03-31 U-1271 2012-09-06 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N202497-001 7887836 2020-03-31 U-1271 2012-09-06 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N202497-001 7247316 2020-09-25 Drug product 2012-09-06 ea99ee380514…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N202497-001 ODE-28 2019-08-09 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N202497-001 ODE-28 2019-08-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202497-001 ODE-28 2019-08-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202497-001 ODE-28 2019-08-09 ea99ee380514…
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 · 2 matching rows.
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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 20536-322 Marqibo Vincristine Sulfate Talon Therapeutics, Inc. NDA Current 72893-008 Marqibo Vincristine Sulfate Acrotech Biopharma LLC NDA Current 72893-008 Marqibo Vincristine Sulfate Acrotech Biopharma LLC NDA Current 72893-008 Marqibo Vincristine Sulfate Acrotech Biopharma LLC NDA Current 72893-008 Marqibo Vincristine Sulfate Acrotech Biopharma LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 70552 SUPPL 2022-03-17 70528 SUPPL 2022-03-16 63825 SUPPL 2020-07-08 63468 SUPPL 2020-06-09 63465 SUPPL 2020-06-09 61513 SUPPL 2020-01-06 44858 ORIG 2013-09-03 43404 ORIG 2013-09-03 32267 ORIG 2012-08-10 19353 ORIG 2012-08-09