Application 216395
- Type
- NDA
- Sponsor
- SOLUBIOMIX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | QUIOFIC | FOLIC ACID | SOLUTION;ORAL | 0.2MG/ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N216395-001 | QUIOFIC | FOLIC ACID | 0.2MG/ML | SOLUTION / ORAL | RLD, RS | 2026-01-26 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N216395-001 | QUIOFIC | 0.2MG/ML | SOLUTION / ORAL | RLD, RS | 2026-01-26 | 011fe1cb6892… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216395-001 | QUIOFIC | 0.2MG/ML | SOLUTION / ORAL | RLD, RS | 2026-01-26 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| FOLIC ACID | FOLIC ACID | Ayurax, LLC | 96618bf8-6c03-4df3-9896-b7ef27ca392a | 2026-02-11 | Warnings, Adverse reactions | 216395 NDA216395 |
| QUIOFIC | FOLIC ACID | Solubiomix, LLC | b868b314-591d-458b-be82-2bcd0b73cce1 | 2026-02-08 | Warnings, Adverse reactions | 216395 NDA216395 |