FDA.reportPublic FDA data

Application 219991

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPHEDRINE SULFATEEPHEDRINE SULFATESOLUTION;INTRAVENOUS50MG/10ML (5MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A219991-001EPHEDRINE SULFATEEPHEDRINE SULFATE50MG/10ML (5MG/ML)SOLUTION / INTRAVENOUSAP22026-03-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A219991-001AP2

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
2026-09-14 22:38:342026-08A219991-001EPHEDRINE SULFATE50MG/10ML (5MG/ML)SOLUTION / INTRAVENOUSAP22026-03-1984e616aacf4f…
2026-08-18 06:07:402026-07A219991-001EPHEDRINE SULFATE50MG/10ML (5MG/ML)SOLUTION / INTRAVENOUSAP22026-03-19caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219991-001EPHEDRINE SULFATE50MG/10ML (5MG/ML)SOLUTION / INTRAVENOUSAP22026-03-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219991-001AP2184e616aacf4f…
2026-08-18 06:07:402026-07A219991-001AP21caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219991-001AP21a50c72e98297…

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 2 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ephedrine sulfateEPHEDRINE SULFATEMedical Purchasing Solutions, LLC08f5ec19-7b53-681b-e063-6294a90acc862023-10-30Warnings, Adverse reactionsName fallback
brand name: Ephedrine sulfate
generic name: EPHEDRINE SULFATE
Ephedrine sulfateEPHEDRINE SULFATEDr. Reddy's Laboratories, Inc.1d1c41c1-8f5f-ee76-c890-4f1f2a3b2e962023-08-01Warnings, Adverse reactionsName fallback
brand name: Ephedrine sulfate
generic name: EPHEDRINE SULFATE
EPHEDRINE SULFATEEPHEDRINE SULFATEPar Health USA, LLCa247857e-ba7b-4a37-b132-4ba9b0d1c4d12023-05-31Warnings, Adverse reactionsName fallback
brand name: EPHEDRINE SULFATE
generic name: EPHEDRINE SULFATE
Ephedrine SulfateEPHEDRINE SULFATEMedical Purchasing Solutions, LLCd163ff39-d1a4-b61f-e053-2995a90ab6d52023-05-02Warnings, Adverse reactionsName fallback
brand name: Ephedrine Sulfate
generic name: EPHEDRINE SULFATE
Ephedrine SulfateEPHEDRINE SULFATEMedical Purchasing Solutions, LLCc8e8ec0e-988b-85a1-e053-2a95a90a22682023-04-25Warnings, Adverse reactionsName fallback
brand name: Ephedrine Sulfate
generic name: EPHEDRINE SULFATE
Ephedrine SulfateEPHEDRINE SULFATEXiromed, LLC8302176c-d443-97f1-1a49-12b9a204121a2023-04-11Warnings, Adverse reactionsName fallback
brand name: Ephedrine Sulfate
generic name: EPHEDRINE SULFATE
Ephedrine SulfateEPHEDRINE SULFATECivica, Inc.8f6c6588-77b6-40c7-a897-52e881854d7f2023-03-31Warnings, Adverse reactionsName fallback
brand name: Ephedrine Sulfate
generic name: EPHEDRINE SULFATE
Ephedrine SulfateEPHEDRINE SULFATESagent Pharmaceuticals614e6649-a0e1-4428-855b-363abdb126d82023-03-03Warnings, Adverse reactionsName fallback
brand name: Ephedrine Sulfate
generic name: EPHEDRINE SULFATE
ephedrine sulfateEPHEDRINE SULFATEBaxter Healthcare Corporation552c341b-4892-4dc7-8b9f-cb6be914b0d12023-01-20Warnings, Adverse reactionsName fallback
brand name: ephedrine sulfate
generic name: EPHEDRINE SULFATE
EmerphedEPHEDRINE SULFATENexus Pharamaceuticals Inc.e1323592-dc57-4c9d-b84d-442648a7b1142022-09-30Warnings, Adverse reactionsName fallback
generic name: EPHEDRINE SULFATE
Ephedrine SulfateEPHEDRINE SULFATEFresenius Kabi USA, LLC5ecd9746-25c7-4bd4-9503-eb97e7db5aa52022-08-24Warnings, Adverse reactionsName fallback
brand name: Ephedrine Sulfate
generic name: EPHEDRINE SULFATE
EPHEDRINE SULFATEEPHEDRINE SULFATEPar Health USA, LLC2c203482-8a04-40fc-93d2-74b30dec77422022-04-30Warnings, Adverse reactionsName fallback
brand name: EPHEDRINE SULFATE
generic name: EPHEDRINE SULFATE
Ephedrine sulfateEPHEDRINE SULFATELifestar Pharma LLC49fc67d1-3b30-456b-951c-ca7f703432ab2022-04-22Warnings, Adverse reactionsName fallback
brand name: Ephedrine sulfate
generic name: EPHEDRINE SULFATE
Ephedrine SulfateEPHEDRINE SULFATEGland Pharma Limited4a66e6c1-6d01-46fa-a2da-566fbf6e11a42022-03-04Warnings, Adverse reactionsName fallback
brand name: Ephedrine Sulfate
generic name: EPHEDRINE SULFATE
AkovazEPHEDRINE SULFATEExela Pharma Sciences, LLCe92f3eda-33eb-4b34-9e8b-db8d32a5dbd92020-11-27Warnings, Adverse reactionsName fallback
generic name: EPHEDRINE SULFATE
Ephedrine SulfateEPHEDRINE SULFATESandoz Incc8af7bb5-41da-4f8c-8acd-f489892a0d722020-05-20Warnings, Adverse reactionsName fallback
brand name: Ephedrine Sulfate
generic name: EPHEDRINE SULFATE

Reported adverse events (FAERS/openFDA)#

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