Drug company (FDA labeler)
Coral Way Pharma, LLC
NDC labeler code: 85437
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Sertaconazole nitrateErtaczo · 1 product
- AuranofinRidaura · 1 product
- Fenoprofen calciumFenopron Tm · 1 product
- Halobetasol propionateBryhali, Lexette, Ultravate · 1 product
- Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| May 16, 2023 | ANDA215548 | Fenoprofen calcium FENOPROFEN CALCIUM | Misemer |
| May 31, 2017 | ANDA208170 | Cyclobenzaprine hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE | Rubicon Research |
| November 6, 2015 | NDA208183 | Halobetasol propionate ULTRAVATE | Lacer Pharma |
| December 10, 2003 | NDA021385 | Sertaconazole nitrate ERTACZO | Lacer Pharma |
| May 24, 1985 | NDA018689 | Auranofin RIDAURA | Legacy |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026