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 5 of 6 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2023-12-20 04:57 UTC2023-12N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19823a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

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