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 3 of 3 · 60 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Folic AcidFOLIC ACIDNuCare Pharmaceuticals, Inc.3f14442c-81ad-0bad-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDA-S Medication Solutions16f8a1a1-ee81-4cd3-85e7-e1eae83fad672024-07-22Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDA-S Medication Solutionsb48f4a4e-ece7-4bbb-b659-ed446cd9f0c92024-07-22Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDNuCare Pharmaceuticals,Inc.7873790c-d722-cd9a-e053-2991aa0a23a32024-06-12Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDProficient Rx LP32203472-8724-4ba7-b0be-d834c3d7f0742024-06-01Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDAphena Pharma Solutions - Tennessee, LLC141bb721-cd20-5bba-e063-6394a90ab8fa2024-03-20Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDModavar Pharmaceuticals LLC0eea15e4-7e5d-44e9-818b-a0bdf5271c782023-12-25Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDCadila Pharmaceuticals Limited103c2cdd-5822-48ba-b62a-e2b11aa444ef2023-12-23Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDBryant Ranch Prepack0b263a1e-260b-4775-a76e-766add336f122023-12-04Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDA-S Medication Solutions21f7ccf1-1de6-4a6e-b017-2b85c9d62d132023-10-19Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAphena Pharma Solutions - Tennessee, LLCf8ffce0d-2b94-4a14-a08e-97646436cf6d2023-06-15Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDA-S Medication Solutionsa9583b76-822d-486a-947a-2be6356637d02023-05-09Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
VitrexylFOLIC ACIDPureTek Corporationae064a9e-daba-fa86-e053-2a95a90a16a72023-01-11Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
VitrexateFOLIC ACIDPureTek Corporationb34fee43-bea9-45b7-e053-2a95a90aad4d2023-01-11Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
VenexaFOLIC ACIDPureTek Corporationba130779-cdfd-086d-e053-2a95a90a25902023-01-11Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDAphena Pharma Solutions - Tennessee, LLCdc4d097d-6e7e-4229-9853-04c31444d7032022-08-12Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDProficient Rx LP607d23e8-21ef-4d73-88f1-990cf267d22e2022-04-01Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic acidFOLIC ACIDAphena Pharma Solutions - Tennessee, LLC454f9fdc-fd8c-4838-8e5b-10f4c74110dd2021-05-24Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDLeading Pharma, LLC1ba8c407-9613-4319-ac40-0a429cb0f3f42019-02-19Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAphena Pharma Solutions - Tennessee, LLCd6c7ac9b-f44a-4f10-9d1d-efbebd37c3132019-02-12Warnings, 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