Register entry
- Registered sites
- 1
- Active NDC listings
- 20
- Labeller names
- 4
- Live patents
- 2
- Countries
- 1
- Base
- United States
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Saptalis Pharmaceuticals, LLC | 20 Davids Drive, Hauppauge, New York (NY) 11788, United States (USA) | Finished drug manufacture | 3012152381081154447 |
Catalogue
Drug listings by form and route
2020 active NDC listings: 20 human prescription drug. By marketing category: ANDA 18, NDA 1, NDA AUTHORIZED GENERIC 1.
| Dosage form | NDCs |
|---|---|
| solution | 11 |
| cream | 3 |
| concentrate | 2 |
| emulsion | 1 |
| gel | 1 |
| lotion | 1 |
| suspension | 1 |
| Route | NDCs |
|---|---|
| oral | 11 |
| topical | 6 |
| auricular (otic) | 1 |
| ophthalmic | 1 |
| vaginal | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| saptalis pharmaceuticals, llc. | 11 |
| saptalis pharmaceuticals, llc | 7 |
| saptalis pharmaceuticals llc | 1 |
| saptalis pharmaceuticals, llc llc | 1 |
Exclusivity
Patents and exclusivities
2| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 12257236 | LIKMEZmetronidazole | product | Jan 2039 |
| 11541035 | LIKMEZmetronidazole | product | Oct 2039 |
Catalogue
Marketed products
20| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| CYCLOSPORINE | CYCLOSPORINE | emulsion, ophthalmic | 71656-012ANDA |
| Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | concentrate, oral | 71656-101ANDA |
| Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | concentrate, oral | 71656-102ANDA |
| DESOXIMETASONE | DESOXIMETASONE | cream, topical | 71656-087ANDA |
| Desoximetasone | Desoximetasone | cream, topical | 71656-086ANDA |
| FLUOXETINE | FLUOXETINE | solution, oral | 71656-089ANDA |
| Fluocinonide | Fluocinonide | solution, topical | 71656-094ANDA |
| Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | solution, oral | 71656-090ANDA |
| LIKMEZ | Metronidazole Oral | suspension, oral | 71656-066NDA |
| Levocarnitine | Levocarnitine Oral | solution, oral | 71656-016ANDA |
| Lithium | Lithium | solution, oral | 71656-072ANDA |
| Metformin Hydrochloride Oral Solution | Metformin Hydrochloride | solution, oral | 71656-017ANDA |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE ORAL | solution, oral | 71656-021ANDA |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | solution, oral | 71656-022ANDA |
| Triamcinolone Acetonide | triamcinolone acetonide | lotion, topical | 71656-040ANDA |
| Triamcinolone Acetonide | triamcinolone acetonide | cream, topical | 71656-042ANDA |
| erythromycin topical solution 2% | erythromycin topical solution 2% | solution, topical | 71656-030ANDA |
| glycopyrrolate | glycopyrrolate | solution, oral | 71656-061ANDA |
| hydrocortisone and acetic acid | hydrocortisone and acetic acid otic | solution, auricular (otic) | 71656-064NDA AUTHORIZED GENERIC |
| metronidazole vaginal | metronidazole | gel, vaginal | 71656-067ANDA |
Neighbours
Registered in the same town
10- Amneal Pharmaceuticals of New York, LLCHauppauge, NY
- InvaGen Pharmaceuticals, IncHauppauge, NY
- ScieGen Pharmaceuticals India Private LimitedHauppauge, NY
- American Health Formulations, Inc.HAUPPAUGE, NY
- A&Z Pharmaceutical, Inc.Hauppauge, NY
- AiPing Pharmaceutical, Inc.Hauppauge, NY
- Precare Corp.Hauppauge, NY
- Radha Pharmaceuticals, Inc.Hauppauge, NY
- Tekweld Solutions, Inc.Hauppauge, NY
- United-Guardian, Inc.Hauppauge, NY
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Enquiry
Common questions
- Is Saptalis Pharmaceuticals, LLC FDA approved?
- Saptalis Pharmaceuticals, LLC 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 Saptalis Pharmaceuticals, LLC's drugs manufactured?
- The FDA register lists Hauppauge, NY. Registered operations: finished drug manufacture.
- What drugs does Saptalis Pharmaceuticals, LLC make?
- 20 products are listed under Saptalis Pharmaceuticals, LLC in the openFDA NDC Directory, most often as solution; cream; concentrate. 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.