Home Applications 020098 Application 020098
Type NDA
Sponsor ABBVIE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MIVACRON MIVACURIUM CHLORIDE SOLUTION;INTRAVENOUS EQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER MIVACURIUM CHLORIDE INJECTABLE;INJECTION EQ 0.5MG BASE/ML No No 003 MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER MIVACURIUM CHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/100ML No No 004 MIVACRON MIVACURIUM CHLORIDE SOLUTION;INTRAVENOUS EQ 10MG BASE/5ML (EQ 2MG BASE/ML) Yes No 005 MIVACRON MIVACURIUM CHLORIDE SOLUTION;INTRAVENOUS EQ 20MG BASE/10ML (EQ 2MG BASE/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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020098-001 MIVACRON MIVACURIUM CHLORIDE EQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 1992-01-22 N020098-002 MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER MIVACURIUM CHLORIDE EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1992-01-22 N020098-003 MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER MIVACURIUM CHLORIDE EQ 50MG BASE/100ML INJECTABLE / INJECTION 1992-01-22 N020098-004 MIVACRON MIVACURIUM CHLORIDE EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD 1992-01-22 N020098-005 MIVACRON MIVACURIUM CHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD 1992-01-22
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 6 of 6 · 220 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 N020098-001 MIVACRON EQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 1992-01-22 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020098-002 MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1992-01-22 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020098-003 MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION 1992-01-22 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020098-004 MIVACRON EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD 1992-01-22 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020098-005 MIVACRON EQ 20MG BASE/10ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD 1992-01-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020098-001 MIVACRON EQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 1992-01-22 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020098-002 MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1992-01-22 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020098-003 MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION 1992-01-22 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020098-004 MIVACRON EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD 1992-01-22 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020098-005 MIVACRON EQ 20MG BASE/10ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD 1992-01-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020098-001 MIVACRON EQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 1992-01-22 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020098-002 MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1992-01-22 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020098-003 MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION 1992-01-22 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020098-004 MIVACRON EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD 1992-01-22 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020098-005 MIVACRON EQ 20MG BASE/10ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD 1992-01-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020098-001 MIVACRON EQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 1992-01-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020098-002 MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1992-01-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020098-003 MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION 1992-01-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020098-004 MIVACRON EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD 1992-01-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020098-005 MIVACRON EQ 20MG BASE/10ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD 1992-01-22 a50c72e98297…
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 55044 SUPPL 2018-07-30 55026 SUPPL 2018-07-27 12210 SUPPL 2015-02-03 2016 SUPPL 2010-11-30 34260 SUPPL 2010-11-22 34259 SUPPL 2004-06-09 21148 SUPPL 2004-06-09 2015 SUPPL 2002-06-04 41143 SUPPL 2000-07-03