FDA.reportPublic FDA data

Application 216395

Type
NDA
Sponsor
SOLUBIOMIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUIOFICFOLIC ACIDSOLUTION;ORAL0.2MG/MLYesYes

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
N216395-001QUIOFICFOLIC ACID0.2MG/MLSOLUTION / ORALRLD, RS2026-01-26

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
2026-10-15 13:18:302026-09N216395-001QUIOFIC0.2MG/MLSOLUTION / ORALRLD, RS2026-01-26c2088c7a36db…
2026-09-14 22:38:342026-08N216395-001QUIOFIC0.2MG/MLSOLUTION / ORALRLD, RS2026-01-2684e616aacf4f…
2026-08-18 06:07:402026-07N216395-001QUIOFIC0.2MG/MLSOLUTION / ORALRLD, RS2026-01-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216395-001QUIOFIC0.2MG/MLSOLUTION / ORALRLD, RS2026-01-26011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216395-001QUIOFIC0.2MG/MLSOLUTION / ORALRLD, RS2026-01-26a50c72e98297…

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 3 · 60 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOLIC ACIDFOLIC ACIDBryant Ranch Prepack93580111-3e70-4a87-8834-c7aa99ec75e32025-10-21Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDMethod Pharmaceuticals, LLCb9c315ff-cecb-8b75-e053-2995a90aa2042025-10-21Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepack3d3d6927-6138-485a-ad72-abd7ca167af72025-10-20Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDNCS HealthCare of KY, LLC dba Vangard Labs76f51124-1e0f-499b-a6d1-7b4dbf313ca02025-09-15Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDPD-Rx Pharmaceuticals, Inc.726bb436-69e3-452f-9f28-153b58bf3ca52025-03-13Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDPreferred Pharmaceuticals Inc.a4fd896d-0a44-4e53-bbb0-d716765e58b12025-02-13Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDCoupler LLC2d98f4c3-9b7a-f122-e063-6294a90a6a002025-02-07Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDNuCare Pharmaceuticals,Inc.fa43f66c-9ae4-cd36-e053-6394a90a15262025-02-04Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDNuCare Pharmaceuticals,Inc.065e403b-7ba8-b584-e063-6294a90a15ec2025-01-31Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDBryant Ranch Prepack0e7cb7ea-c94e-4ce6-8149-311dc9c94e032025-01-28Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepackceedca87-e390-4123-8de5-8c2a28bd03772025-01-21Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDDIRECT RXbfcb0849-6d9b-7705-e053-2a95a90a65412025-01-17Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
VentrixylFOLIC ACIDPureTek Corporationc29dc729-93be-2a20-e053-2a95a90a8ca32024-12-03Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDSUNRISE PHARMACEUTICAL, INC.6854412b-7ecb-4107-85eb-730f14e23f062024-12-03Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepackf4ede23e-f091-46cb-b120-772ee71b8cb32024-10-31Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic acidFOLIC ACIDChartwell RX, LLC.9a533666-8906-438e-adf7-11bb162ecb632024-10-28Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAmneal Pharmaceuticals LLCc8fe09f0-b32b-43e3-8de7-ed38593b33b42024-10-25Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepackfd0ec9f8-f547-4e5a-9847-a7ddfc3344bc2024-10-15Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDFresenius Kabi USA, LLCe215318c-4f8b-4711-ae76-f370d1da0f3b2024-10-14Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepack1b050122-73e9-48c7-9b26-431eaadddcfe2024-08-23Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85526ORIG 2026-03-25
85392ORIG 2026-03-12
84840ORIG 2026-01-27