Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022186
Company: LONG GROVE PHARMS
Company: LONG GROVE PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AK-FLUOR 10% | FLUORESCEIN SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | AP | Yes | Yes |
| AK-FLUOR 25% | FLUORESCEIN SODIUM | EQ 500MG BASE/2ML (EQ 250MG BASE/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/17/2026 | SUPPL-15 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022186Orig1s015lbl.pdf |
| 02/28/2025 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022186Orig1s013lbl.pdf | |
| 02/28/2025 | SUPPL-13 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022186Orig1s013lbl.pdf |