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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/08/2008 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
Review Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022186s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022186_akfluor_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022186s000_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/28/2025 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022186Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022186Orig1s013ltr.pdf | |
07/20/2015 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/28/2025 | SUPPL-13 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022186Orig1s013lbl.pdf | |
02/28/2025 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022186Orig1s013lbl.pdf |
AK-FLUOR 10%
INJECTABLE;INTRAVENOUS; EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AK-FLUOR 10% | FLUORESCEIN SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 022186 | LONG GROVE PHARMS |
FLUORESCEIN SODIUM | FLUORESCEIN SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215709 | NEXUS |
FLUORESCITE | FLUORESCEIN SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 021980 | ALCON LABS INC |
AK-FLUOR 25%
There are no Therapeutic Equivalents.