Application 020326

Type
NDA
Sponsor
MEDIMMUNE ONCOLOGY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEUTREXINTRIMETREXATE GLUCURONATEINJECTABLE;INJECTIONEQ 25MG BASE/VIALNoNo
002NEUTREXINTRIMETREXATE GLUCURONATEINJECTABLE;INJECTIONEQ 200MG BASE/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020326-001NEUTREXINTRIMETREXATE GLUCURONATEEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-17
N020326-002NEUTREXINTRIMETREXATE GLUCURONATEEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-31

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 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020326-001NEUTREXINEQ 25MG BASE/VIALINJECTABLE / INJECTION1993-12-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020326-002NEUTREXINEQ 200MG BASE/VIALINJECTABLE / INJECTION1998-07-31bb7c543d1eb4…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
2333SUPPL2005-11-18
12446SUPPL2005-11-17
34503SUPPL2002-06-26
24778SUPPL2002-06-26
24777SUPPL2002-06-26
12445SUPPL2002-06-26