FDA.reportPublic FDA data

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 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d2026-07-22Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
ampicillin and sulbactamAMPICILLIN AND SULBACTAMSagent Pharmaceuticalsa67ae347-487d-4751-a841-b321e81db26f2026-07-21Warnings, Adverse reactionsName fallback
brand name: ampicillin and sulbactam
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC72a37674-8cb2-4b40-aac8-d345ffcf22f22026-06-23Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC9a722de6-9dc0-4fb9-b63a-225385aa33142026-06-23Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC77158167-0c1e-4f01-a5b0-a3df8ad121f52026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.e6cf14a8-3ed9-4a7a-ba69-be0b794cbdc42026-06-10Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMedical Purchasing Solutions, LLC.4e81c215-2ab6-87c6-e063-6294a90ac28c2026-04-02Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMHikma Pharmaceuticals USA Inc.a65a70bf-4283-4bc0-b576-00c9ab29bd642026-03-25Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMHikma Pharmaceuticals USA Inc.d3026cc0-95d8-44cf-be47-b5ebb8fd45682026-03-25Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMHospira, Incdc374fa4-350b-425d-a7db-7099fdc64cf12026-01-21Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMEugia US LLC437a26f4-776b-4f74-99b2-09ad79831b0c2025-12-18Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMEugia US LLC16fdfdb9-9e26-48d0-8838-570d30c8e8972025-11-04Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMEugia US LLCadc92303-b62b-41c8-becf-9c3a4e8c3a6b2025-08-12Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMEugia US LLC2709e9fc-2341-4382-af72-c2e3201bd77a2025-08-12Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.9f2ff165-2a21-4155-a4f0-57885a83c7dc2025-07-24Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMAvenacy, LLC577dd6f0-d56a-4c82-9f72-274c3a4a0f012025-04-25Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMAvenacy, LLC4446d4c8-056d-4bc3-8f58-21255b0633982025-04-25Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.139b4b2e-46f7-44a8-9cc1-774afa463b802025-04-24Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam
ampicillin and sulbactamAMPICILLIN AND SULBACTAMSagent Pharmaceuticals35606b43-5914-423c-9bc7-fa3957eb25632024-11-18Warnings, Adverse reactionsName fallback
brand name: ampicillin and sulbactam
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMNorthStar Rx, LLC5e8d35cb-e93d-42ad-a02c-0dbf04910f612024-08-13Warnings, Adverse reactionsName fallback
brand name: Ampicillin and Sulbactam