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 43.

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 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050550-001MOXAMEQ 250MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050550-002MOXAMEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050550-003MOXAMEQ 1GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050550-004MOXAMEQ 2GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050550-008MOXAMEQ 10GM BASE/VIALINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
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…

Reported adverse events (FAERS/openFDA)#

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