Application 050550

Type
NDA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOXAMMOXALACTAM DISODIUMINJECTABLE;INJECTIONEQ 250MG BASE/VIALNoNo
002MOXAMMOXALACTAM DISODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
003MOXAMMOXALACTAM DISODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
004MOXAMMOXALACTAM DISODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo
008MOXAMMOXALACTAM DISODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIALNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050550-001MOXAMMOXALACTAM DISODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982
N050550-002MOXAMMOXALACTAM DISODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982
N050550-003MOXAMMOXALACTAM DISODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982
N050550-004MOXAMMOXALACTAM DISODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982
N050550-008MOXAMMOXALACTAM DISODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982

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 4 of 6 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2021-03-12 10:30 UTC2021-03N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19821c564ffb4f44…

Reported adverse events (FAERS/openFDA)#

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