Register entry
- Registered sites
- 1
- Active NDC listings
- 10
- Live patents
- 0
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1Relabelling1Repackaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| POLYGEN PHARMACEUTICALS INC. | 41 Mercedes Way, Unit 17, Edgewood, New York (NY) 11717, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging | 3008383084962415720 |
Catalogue
Drug listings by form and route
1010 active NDC listings: 10 human prescription drug. By marketing category: ANDA 10.
| Dosage form | NDCs |
|---|---|
| tablet | 6 |
| tablet, extended release | 2 |
| tablet, film coated | 2 |
| Route | NDCs |
|---|---|
| oral | 10 |
| Labeller name on the listing | NDCs |
|---|---|
| polygen pharmaceuticals inc. | 10 |
Catalogue
Marketed products
10| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Clopidogrel | Clopidogrel | tablet, oral | 52605-083ANDA |
| Darifenacin | Darifenacin Hydrobromide | tablet, extended release, oral | 52605-067ANDA |
| Darifenacin | Darifenacin Hydrobromide | tablet, extended release, oral | 52605-068ANDA |
| Memantine hydrochloride | Memantine hydrochloride | tablet, film coated, oral | 52605-072ANDA |
| Phentermine hydrochloride | Phentermine hydrochloride | tablet, oral | 52605-022ANDA |
| amlodipine besylate | amlodipine besylate | tablet, oral | 52605-041ANDA |
| amlodipine besylate | amlodipine besylate | tablet, oral | 52605-042ANDA |
| amlodipine besylate | amlodipine besylate | tablet, oral | 52605-043ANDA |
| clopidogrel | clopidogrel | tablet, oral | 52605-082ANDA |
| memantine hydrochloride | memantine hydrochloride | tablet, film coated, oral | 52605-071ANDA |
Neighbours
Registered in the same town
1- Healthcare Sales and Service, LLCEdgewood, NY
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Enquiry
Common questions
- Is POLYGEN PHARMACEUTICALS INC. FDA approved?
- POLYGEN PHARMACEUTICALS INC. 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 POLYGEN PHARMACEUTICALS INC.'s drugs manufactured?
- The FDA register lists Edgewood, NY. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, relabelling, repackaging.
- What drugs does POLYGEN PHARMACEUTICALS INC. make?
- 10 products are listed under POLYGEN PHARMACEUTICALS INC. in the openFDA NDC Directory, most often as tablet; tablet, extended release; tablet, film coated. 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.