Register entry
- Registered sites
- 1
- Active NDC listings
- 5
- Labeller names
- 2
- Live patents
- 0
- Countries
- 1
- Base
- United States
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Premier Dental Products Company | 10090 Sandmeyer Lane, Philadelphia, Pennsylvania (PA) 19116, United States (USA) | Finished drug manufacture | 2521453098153067 |
Catalogue
Drug listings by form and route
55 active NDC listings: 2 human otc drug, 2 human prescription drug, 1 drug for further processing. By marketing category: OTC MONOGRAPH DRUG 2, UNAPPROVED DRUG OTHER 2, DRUG FOR FURTHER PROCESSING 1.
| Dosage form | NDCs |
|---|---|
| paste | 2 |
| gel | 1 |
| paste, dentifrice | 1 |
| solution | 1 |
| Route | NDCs |
|---|---|
| dental | 2 |
| topical | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| premier dental products company | 4 |
| premier dental products | 1 |
Catalogue
Marketed products
5| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Benzocaine | solution | 10733-802DRUG FOR FURTHER PROCESSING |
| Enamelon | stannous fluoride | paste, dentifrice, dental | 48783-520OTC MONOGRAPH DRUG |
| Enamelon Preventive Treatment | stannous fluoride | gel, dental | 48783-500OTC MONOGRAPH DRUG |
| Monsels Solution | Ferric Subsulfate | paste, topical | 48783-112UNAPPROVED DRUG OTHER |
| Monsels Solution | Ferric Subsulfate | paste, topical | 48783-113UNAPPROVED DRUG OTHER |
Neighbours
Registered in the same town
8- Catalent Pharma Solutions Inc.Philadelphia, PA
- AstraZeneca PLCPhiladelphia, PA
- Frontida BioPharm, LLCPhiladelphia, PA
- Iovance Biotherapeutics, Inc.Philadelphia, PA
- Medical Products Laboratories, Inc.Philadelphia, PA
- Spark Therapeutics, Inc.Philadelphia, PA
- Trustees of the University of PennsylvaniaPhiladelphia, PA
- USWM CT, LLCPhiladelphia, PA
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Enquiry
Common questions
- Is Premier Dental Products Company FDA approved?
- Premier Dental Products Company 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 Premier Dental Products Company's drugs manufactured?
- The FDA register lists Philadelphia, PA. Registered operations: finished drug manufacture.
- What drugs does Premier Dental Products Company make?
- 5 products are listed under Premier Dental Products Company in the openFDA NDC Directory, most often as paste; gel; paste, dentifrice. 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.