FDA.reportPublic FDA data

Application 088147

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%AMINOPHYLLINEINJECTABLE;INJECTION100MG/100MLNoNo
003AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%AMINOPHYLLINEINJECTABLE;INJECTION200MG/100MLNoNo

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
A088147-002AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%AMINOPHYLLINE100MG/100MLINJECTABLE / INJECTION1983-05-03
A088147-003AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%AMINOPHYLLINE200MG/100MLINJECTABLE / INJECTION1983-05-03

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 22:54:322026-06A088147-002AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%100MG/100MLINJECTABLE / INJECTION1983-05-03a50c72e98297…
2026-08-01 22:54:322026-06A088147-003AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%200MG/100MLINJECTABLE / INJECTION1983-05-03a50c72e98297…

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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMINOPHYLLINEAMINOPHYLLINEHF Acquisition Co LLC, DBA HealthFirst819207a2-0c37-b275-e053-2a91aa0afb362026-06-19Warnings, Adverse reactionsName fallback
generic name: AMINOPHYLLINE
AminophyllineAMINOPHYLLINEMedical Purchasing Solutions, LLC52bbc6cd-4baf-7859-e063-6394a90ac87d2026-05-26Warnings, Adverse reactionsName fallback
generic name: AMINOPHYLLINE
AminophyllineAMINOPHYLLINEHospira, Inc.9a663ef3-881f-48bd-2689-3713b24545c22026-05-22Warnings, Adverse reactionsName fallback
generic name: AMINOPHYLLINE
AminophyllineAMINOPHYLLINEProPharma Distribution3f000254-a9f1-c8c7-e063-6394a90aa33f2025-12-18Warnings, Adverse reactionsName fallback
generic name: AMINOPHYLLINE
AminophyllineAMINOPHYLLINEHenry Schein, Inc.9066bdd0-cb03-40ed-abfa-1b6fb1fff6072025-10-27Warnings, Adverse reactionsName fallback
generic name: AMINOPHYLLINE
AminophyllineAMINOPHYLLINEHenry Schein, Inc.9a9dedc4-ce04-4b22-9922-81a215ff59ed2025-10-27Warnings, Adverse reactionsName fallback
generic name: AMINOPHYLLINE
AMINOPHYLLINEAMINOPHYLLINEHF Acquisition Co LLC, DBA HealthFirst75c2fc3e-28ac-c1b1-e053-2991aa0aee9f2024-01-08Warnings, Adverse reactionsName fallback
generic name: AMINOPHYLLINE
AminophyllineAMINOPHYLLINEMedical Purchasing Solutions, LLC6bca324f-6999-4c16-e053-2a91aa0aee452023-05-30Warnings, Adverse reactionsName fallback
generic name: AMINOPHYLLINE