Application 209708

Type
ANDA
Sponsor
WOODWARD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIVACURIUM CHLORIDEMIVACURIUM CHLORIDESOLUTION;INTRAVENOUSEQ 10MG BASE/5ML (EQ 2MG BASE/ML)NoNo
002MIVACURIUM CHLORIDEMIVACURIUM CHLORIDESOLUTION;INTRAVENOUSEQ 20MG BASE/10ML (EQ 2MG BASE/ML)NoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209708-001MIVACURIUM CHLORIDEMIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12
A209708-002MIVACURIUM CHLORIDEMIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12

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 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-03-09 01:35 UTC2022-03A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12782e0a99824c…
2021-12-28 21:50 UTC2021-12A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-126a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-121c564ffb4f44…
2024-02-18 07:12 UTC2024-02A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-129b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-123f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12053a50430f4f…
2023-05-13 08:27 UTC2023-05A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-123bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-123a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12e64feba35796…
2022-09-29 23:25 UTC2022-09A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209708-001MIVACURIUM CHLORIDEEQ 10MG BASE/5ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209708-002MIVACURIUM CHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)SOLUTION / INTRAVENOUS2021-10-12a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.