FDA.reportPublic FDA data

Application 217906

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMBLAVEOAVIBACTAM SODIUM; AZTREONAMPOWDER;INTRAVENOUSEQ 0.5GM BASE/VIAL;1.5GM/VIALYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217906-001EMBLAVEOAVIBACTAM SODIUM; AZTREONAMEQ 0.5GM BASE/VIAL;1.5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-02-07

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217906-00171125922026-01-07U-4147Drug substance, Drug product2025-03-07
N217906-00176120872026-11-12Drug product2025-03-07
N217906-00188354552030-10-08Drug product2025-03-07
N217906-00184710252031-08-12Drug substance2025-03-07
N217906-00189695662032-06-15Drug substance2025-03-07
N217906-00192843142032-06-15Drug substance2025-03-07
N217906-00196951222032-06-15Drug substance, Drug product2025-03-07

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217906-001NP2028-02-07
N217906-001GAIN2033-02-07

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N217906-001EMBLAVEOEQ 0.5GM BASE/VIAL;1.5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-02-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-001EMBLAVEOEQ 0.5GM BASE/VIAL;1.5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-02-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N217906-001EMBLAVEOEQ 0.5GM BASE/VIAL;1.5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-02-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-001EMBLAVEOEQ 0.5GM BASE/VIAL;1.5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-02-07fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-001EMBLAVEOEQ 0.5GM BASE/VIAL;1.5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-02-07a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N217906-00171125922026-01-07U-4147Drug substance, Drug product2025-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217906-00176120872026-11-12Drug product2025-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217906-00188354552030-10-08Drug product2025-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217906-00184710252031-08-12Drug substance2025-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217906-00189695662032-06-15Drug substance2025-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217906-00192843142032-06-15Drug substance2025-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217906-00196951222032-06-15Drug substance, Drug product2025-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-00171125922026-01-07U-4147Drug substance, Drug product2025-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-00176120872026-11-12Drug product2025-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-00188354552030-10-08Drug product2025-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-00184710252031-08-12Drug substance2025-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-00189695662032-06-15Drug substance2025-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-00192843142032-06-15Drug substance2025-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-00196951222032-06-15Drug substance, Drug product2025-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N217906-00171125922026-01-07U-4147Drug substance, Drug product2025-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217906-00176120872026-11-12Drug product2025-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217906-00188354552030-10-08Drug product2025-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217906-00184710252031-08-12Drug substance2025-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217906-00189695662032-06-15Drug substance2025-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217906-00192843142032-06-15Drug substance2025-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217906-00196951222032-06-15Drug substance, Drug product2025-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-00171125922026-01-07U-4147Drug substance, Drug product2025-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-00176120872026-11-12Drug product2025-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-00188354552030-10-08Drug product2025-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-00184710252031-08-12Drug substance2025-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-00189695662032-06-15Drug substance2025-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-00192843142032-06-15Drug substance2025-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-00196951222032-06-15Drug substance, Drug product2025-03-07fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-00171125922026-01-07U-4147Drug substance, Drug product2025-03-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-00176120872026-11-12Drug product2025-03-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-00188354552030-10-08Drug product2025-03-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-00184710252031-08-12Drug substance2025-03-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-00189695662032-06-15Drug substance2025-03-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-00192843142032-06-15Drug substance2025-03-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-00196951222032-06-15Drug substance, Drug product2025-03-07a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N217906-001NP2028-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217906-001GAIN2033-02-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-001NP2028-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-001GAIN2033-02-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N217906-001NP2028-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217906-001GAIN2033-02-076a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-001NP2028-02-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-001GAIN2033-02-07a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EMBLAVEOAZTREONAM AND AVIBACTAMAbbVie Inc.be1a6c99-d4b3-46d7-9e99-6e5f9fab556a2026-06-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 217906
application number: NDA217906

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85320ORIG 2026-03-10
81182ORIG 2025-02-10
81125ORIG 2025-02-07