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 3 of 6 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-05-31 18:47 UTC2024-05N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 198287673890dc5c…

Reported adverse events (FAERS/openFDA)#

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