Register entry
Saptalis Pharmaceuticals, LLC
- Registered sites
- 1
- Drug products
- 20
- Live patents
- 2
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Finished drug manufacture
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Saptalis Pharmaceuticals, LLC | Hauppauge, NYUnited States | Finished drug manufacture | 3012152381 |
Exclusivity
Patents
2Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| LIKMEZ | METRONIDAZOLE | Jan 2039 |
| LIKMEZ | METRONIDAZOLE | Oct 2039 |
Catalogue
Marketed products
20Showing 20 of 20.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| CYCLOSPORINE | CYCLOSPORINE | EMULSION | ANDA |
| Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | CONCENTRATE | ANDA |
| Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | CONCENTRATE | ANDA |
| DESOXIMETASONE | DESOXIMETASONE | CREAM | ANDA |
| Desoximetasone | Desoximetasone | CREAM | ANDA |
| FLUOXETINE | FLUOXETINE | SOLUTION | ANDA |
| Fluocinonide | Fluocinonide | SOLUTION | ANDA |
| Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | SOLUTION | ANDA |
| LIKMEZ | Metronidazole Oral | SUSPENSION | NDA |
| Levocarnitine | Levocarnitine Oral | SOLUTION | ANDA |
| Lithium | Lithium | SOLUTION | ANDA |
| Metformin Hydrochloride Oral Solution | Metformin Hydrochloride | SOLUTION | ANDA |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE ORAL | SOLUTION | ANDA |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | SOLUTION | ANDA |
| Triamcinolone Acetonide | triamcinolone acetonide | LOTION | ANDA |
| Triamcinolone Acetonide | triamcinolone acetonide | CREAM | ANDA |
| erythromycin topical solution 2% | erythromycin topical solution 2% | SOLUTION | ANDA |
| glycopyrrolate | glycopyrrolate | SOLUTION | ANDA |
| hydrocortisone and acetic acid | hydrocortisone and acetic acid otic | SOLUTION | NDA AUTHORIZED GENERIC |
| metronidazole vaginal | metronidazole | GEL | ANDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.