Application 090653

Type
ANDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALNoNo
002AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090653-001AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTION2011-12-21
A090653-002AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTION2011-12-21

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
2026-08-01 22:54:322026-06A090653-001AMPICILLIN AND SULBACTAMEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTION2011-12-21a50c72e98297…
2026-08-01 22:54:322026-06A090653-002AMPICILLIN AND SULBACTAMEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALINJECTABLE / INJECTION2011-12-21a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMNorthStar Rx, LLC1e5004f1-e79e-4e0b-9f3f-25f6bbc152552024-06-27Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam