Register entry
- Registered sites
- 1
- Active NDC listings
- 2
- Labeller names
- 2
- Live patents
- 7
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| QOL Medical, LLCRegistrant: QOL MEDICAL | 11236 47TH ST N, CLEARWATER, Florida (FL) 33762, United States (USA) | Analytical testing, Active ingredient (API) manufacture | 3014492051104085889 |
Catalogue
Drug listings by form and route
22 active NDC listings: 2 human prescription drug. By marketing category: BLA 1, NDA 1.
| Dosage form | NDCs |
|---|---|
| injection, solution | 1 |
| solution | 1 |
| Route | NDCs |
|---|---|
| intravenous | 1 |
| oral | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| qol medical, llc | 1 |
| qol medical, llc. | 1 |
Exclusivity
Patents and exclusivities
7| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 11020361 | GIMOTImetoclopramide hydrochloride | use | Dec 2029 |
| 11628150 | GIMOTImetoclopramide hydrochloride | product | Dec 2029 |
| 11813231 | GIMOTImetoclopramide hydrochloride | product | Dec 2029 |
| 12194008 | GIMOTImetoclopramide hydrochloride | use | Dec 2029 |
| 12194009 | GIMOTImetoclopramide hydrochloride | use | Dec 2029 |
| 8334281 | GIMOTImetoclopramide hydrochloride | product | May 2030 |
| 12377064 | GIMOTImetoclopramide hydrochloride | use | Nov 2038 |
Catalogue
Marketed products
2| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Ethamolin | Ethanolamine Oleate | injection, solution, intravenous | 67871-479NDA |
| Sucraid | sacrosidase | solution, oral | 67871-111BLA |
Neighbours
Registered in the same town
2- CORERX, INC.Clearwater, FL
- SURPRISE ENTERPRISE LLCClearwater, FL
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Enquiry
Common questions
- Is QOL MEDICAL FDA approved?
- QOL MEDICAL holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are QOL MEDICAL's drugs manufactured?
- The FDA register lists CLEARWATER, FL. Registered operations: analytical testing, active ingredient (API) manufacture.
- What drugs does QOL MEDICAL make?
- 2 products are listed under QOL MEDICAL in the openFDA NDC Directory, most often as injection, solution; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.