Home Applications 019763 Application 019763
Type NDA
Sponsor BAXTER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IFEX IFOSFAMIDE INJECTABLE;INJECTION 1GM/VIAL Yes No 002 IFEX IFOSFAMIDE INJECTABLE;INJECTION 3GM/VIAL Yes No 003 IFEX/MESNEX KIT IFOSFAMIDE; MESNA INJECTABLE;INJECTION 1GM/VIAL;100MG/ML No No 004 IFEX/MESNEX KIT IFOSFAMIDE; MESNA INJECTABLE;INJECTION 3GM/VIAL;100MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019763-001 IFEX IFOSFAMIDE 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 N019763-002 IFEX IFOSFAMIDE 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 N019763-003 IFEX/MESNEX KIT IFOSFAMIDE; MESNA 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 N019763-004 IFEX/MESNEX KIT IFOSFAMIDE; MESNA 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 of 5 · 176 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UTC 2019-12 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 ea99ee380514…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
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 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0338-3991 IFEX ifosfamide Baxter Healthcare Corporation NDA Current 0338-3991 IFEX ifosfamide Baxter Healthcare Corporation NDA Current 0338-3991 IFEX ifosfamide Baxter Healthcare Corporation NDA Current 0338-3991 IFEX ifosfamide Baxter Healthcare Corporation NDA Current 0338-3993 IFEX ifosfamide Baxter Healthcare Corporation NDA Current 0338-3993 IFEX ifosfamide Baxter Healthcare Corporation NDA Current 0338-3993 IFEX ifosfamide Baxter Healthcare Corporation NDA Current 0338-3993 IFEX ifosfamide Baxter Healthcare Corporation NDA Current 10019-925 IFOSFAMIDE IFOSFAMIDE Baxter Healthcare Corporation NDA Current 10019-925 IFOSFAMIDE IFOSFAMIDE Baxter Healthcare Corporation NDA Current 10019-925 IFOSFAMIDE IFOSFAMIDE Baxter Healthcare Corporation NDA Current 10019-925 IFOSFAMIDE IFOSFAMIDE Baxter Healthcare Corporation NDA Current 10019-926 IFOSFAMIDE IFOSFAMIDE Baxter Healthcare Corporation NDA Current 10019-926 IFOSFAMIDE IFOSFAMIDE Baxter Healthcare Corporation NDA Current 10019-926 IFOSFAMIDE IFOSFAMIDE Baxter Healthcare Corporation NDA Current 10019-926 IFOSFAMIDE IFOSFAMIDE Baxter Healthcare Corporation NDA Current 10019-927 IFOSFAMIDE ifosfamide Baxter Healthcare Corporation NDA Current 10019-927 IFOSFAMIDE ifosfamide Baxter Healthcare Corporation NDA Current 10019-927 IFOSFAMIDE ifosfamide Baxter Healthcare Corporation NDA Current 10019-927 IFOSFAMIDE ifosfamide Baxter Healthcare Corporation NDA Current 10019-929 IFOSFAMIDE ifosfamide Baxter Healthcare Corporation NDA Current 10019-929 IFOSFAMIDE ifosfamide Baxter Healthcare Corporation NDA Current 10019-929 IFOSFAMIDE ifosfamide Baxter Healthcare Corporation NDA Current 10019-929 IFOSFAMIDE ifosfamide Baxter Healthcare Corporation NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 80484 SUPPL 2024-12-03 80476 SUPPL 2024-12-03 55092 SUPPL 2018-08-03 55079 SUPPL 2018-08-02 33916 SUPPL 2014-09-03 1576 SUPPL 2014-09-02 33915 SUPPL 2012-03-06 19155 SUPPL 2012-03-05 33914 SUPPL 2011-03-28 19154 SUPPL 2011-03-25