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 2 of 6 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19821e350fbaab3a…

Reported adverse events (FAERS/openFDA)#

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