FDA.reportPublic FDA data

Application 090064

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAFFEINE CITRATECAFFEINE CITRATESOLUTION;ORALEQ 30MG BASE/3ML (EQ 10MG BASE/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A090064-001CAFFEINE CITRATECAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORAL2009-11-20

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A090064-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORAL2009-11-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090064-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORAL2009-11-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090064-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORAL2009-11-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090064-001CAFFEINE CITRATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)SOLUTION / ORAL2009-11-20a50c72e98297…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAFFEINE CITRATECAFFEINE CITRATEMicro Labs Limited279a43b8-9ff5-4792-ac19-441f3fa492692026-08-01Warnings, Adverse reactionsName fallback
brand name: CAFFEINE CITRATE
generic name: CAFFEINE CITRATE
Caffeine CitrateCAFFEINE CITRATEMicro Labs Limiteddb4477a3-b291-4b77-9eca-b7ba8f66b2be2026-08-01Warnings, Adverse reactionsName fallback
brand name: Caffeine Citrate
generic name: CAFFEINE CITRATE
caffeine citrateCAFFEINE CITRATESagent Pharmaceuticals5f38c395-0093-4afd-89ec-f96e5dc0934a2026-07-29Warnings, Adverse reactionsName fallback
brand name: caffeine citrate
generic name: CAFFEINE CITRATE
Caffeine CitrateCAFFEINE CITRATEEugia US LLC8ef448ca-5549-4272-a6b4-5c4f57653c4c2025-04-19Warnings, Adverse reactionsName fallback
brand name: Caffeine Citrate
generic name: CAFFEINE CITRATE
Caffeine CitrateCAFFEINE CITRATEHikma Pharmaceuticals USA Inc.21489401-f2a7-47d3-897a-4b7efa04dd7a2024-04-08Warnings, Adverse reactionsName fallback
brand name: Caffeine Citrate
generic name: CAFFEINE CITRATE
Caffeine Citrate Oral SolutionCAFFEINE CITRATEArmas Pharmaceuticals Inc.2bd238d4-4657-4341-9c28-1b468b8f3bf82023-07-31Warnings, Adverse reactionsName fallback
generic name: CAFFEINE CITRATE
Caffeine CitrateCAFFEINE CITRATEFresenius Kabi USA, LLCbaf9f88a-776a-44e7-82cc-8f0ca419572f2023-07-20Warnings, Adverse reactionsName fallback
brand name: Caffeine Citrate
generic name: CAFFEINE CITRATE
CAFFEINE CITRATECAFFEINE CITRATEArmas Pharmaceuticals Inc.c1129235-f7f6-43eb-8d6e-786c14c16f2f2023-07-18Warnings, Adverse reactionsName fallback
brand name: CAFFEINE CITRATE
generic name: CAFFEINE CITRATE
Caffeine CitrateCAFFEINE CITRATEFresenius Kabi USA, LLC38b39044-737a-4247-a6c4-c86f5e92490e2023-07-14Warnings, Adverse reactionsName fallback
brand name: Caffeine Citrate
generic name: CAFFEINE CITRATE
Caffeine CitrateCAFFEINE CITRATESun Pharmaceutical Industries, Inc.cc632825-e0a4-4524-8d7d-ce926efab3d62020-12-12Warnings, Adverse reactionsName fallback
brand name: Caffeine Citrate
generic name: CAFFEINE CITRATE
Caffeine CitrateCAFFEINE CITRATESun Pharmaceutical Industries, Inc.d06d3810-9923-4199-be5e-ee5ee086b0a42019-03-01Warnings, Adverse reactionsName fallback
brand name: Caffeine Citrate
generic name: CAFFEINE CITRATE
Caffeine CitrateCAFFEINE CITRATEFresenius Kabi USA, LLCb4fb7c77-1e82-48b7-83c5-dd04ec7c5c4e2019-02-28Warnings, Adverse reactionsName fallback
brand name: Caffeine Citrate
generic name: CAFFEINE CITRATE
caffeine citrateCAFFEINE CITRATEExela Pharma Sciences, LLCf423a220-e7bf-4d24-bc52-bafc1864265b2015-03-30Warnings, Adverse reactionsName fallback
brand name: caffeine citrate
generic name: CAFFEINE CITRATE
caffeine citrateCAFFEINE CITRATEExela Pharma Sciences, LLC5d05ebf4-fd27-3bd1-5634-b41e33abc41f2015-03-26Warnings, Adverse reactionsName fallback
brand name: caffeine citrate
generic name: CAFFEINE CITRATE

Reported adverse events (FAERS/openFDA)#

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