Register entry
- Registered sites
- 1
- Active NDC listings
- 23
- Labeller names
- 2
- Live patents
- 0
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Labelling1Finished drug manufacture1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Waylis Therapeutics | 2131 Felver Court Suite B, Rahway, New Jersey (NJ) 07065, United States (USA) | Labelling, Finished drug manufacture | 3021614574117678921 |
Catalogue
Drug listings by form and route
2323 active NDC listings: 23 human prescription drug. By marketing category: NDA 20, ANDA 3.
| Dosage form | NDCs |
|---|---|
| capsule | 8 |
| tablet, film coated | 6 |
| capsule, extended release | 4 |
| tablet, coated | 3 |
| tablet | 1 |
| tablet, delayed release | 1 |
| Route | NDCs |
|---|---|
| oral | 23 |
| Labeller name on the listing | NDCs |
|---|---|
| waylis therapeutics llc | 22 |
| waylis therapeutics | 1 |
Catalogue
Marketed products
23| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Aciphex | rabeprazole sodium | tablet, delayed release, oral | 80725-243NDA |
| Coreg | Carvedilol | tablet, film coated, oral | 80725-139NDA |
| Coreg | Carvedilol | tablet, film coated, oral | 80725-140NDA |
| Coreg | Carvedilol | tablet, film coated, oral | 80725-141NDA |
| Coreg | Carvedilol | tablet, film coated, oral | 80725-142NDA |
| Coreg CR | Carvedilol Phosphate | capsule, extended release, oral | 80725-383NDA |
| Coreg CR | Carvedilol Phosphate | capsule, extended release, oral | 80725-385NDA |
| Coreg CR | Carvedilol Phosphate | capsule, extended release, oral | 80725-387NDA |
| Coreg CR | Carvedilol Phosphate | capsule, extended release, oral | 80725-388NDA |
| DROXIA | Hydroxyurea | capsule, oral | 80725-820NDA |
| DROXIA | Hydroxyurea | capsule, oral | 80725-830NDA |
| DROXIA | Hydroxyurea | capsule, oral | 80725-840NDA |
| Eulexin | Flutamide | capsule, oral | 80725-143ANDA |
| Eulexin | Flutamide | capsule, oral | 80725-600ANDA |
| HYDREA | Hydroxyurea | capsule, oral | 80725-810NDA |
| Humatin | PAROMOMYCIN SULFATE | capsule, oral | 80725-250ANDA |
| Jalyn | DUTASTERIDE and TAMSULOSIN HYDROCHLORIDE | capsule, oral | 80725-809NDA |
| LEUKERAN | chlorambucil | tablet, film coated, oral | 80725-610NDA |
| Lunesta | ESZOPICLONE | tablet, coated, oral | 80725-010NDA |
| Lunesta | ESZOPICLONE | tablet, coated, oral | 80725-011NDA |
| Lunesta | ESZOPICLONE | tablet, coated, oral | 80725-012NDA |
| MYLERAN | busulfan | tablet, film coated, oral | 80725-620NDA |
| TABLOID | thioguanine | tablet, oral | 80725-630NDA |
Neighbours
Registered in the same town
1- Sunrise Pharmaceutical IncRahway, NJ
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Enquiry
Common questions
- Is Waylis Therapeutics FDA approved?
- Waylis Therapeutics 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 Waylis Therapeutics's drugs manufactured?
- The FDA register lists Rahway, NJ. Registered operations: labelling, finished drug manufacture.
- What drugs does Waylis Therapeutics make?
- 23 products are listed under Waylis Therapeutics in the openFDA NDC Directory, most often as capsule; tablet, film coated; capsule, extended release. 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.