Register entry
Sebela Pharmaceuticals Inc.
- Registered sites
- 0
- Drug products
- 12
- Live patents
- 1
- Countries
- 0
- Base
- Unknown
Sites
Facilities
0No registered facilities
This company holds drug listings or approvals but operates no registered establishment of its own, which is normal for an NDA holder that outsources manufacturing.
Exclusivity
Patents
1Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ONMEL | ITRACONAZOLE | Oct 2028 |
Catalogue
Marketed products
12Showing 12 of 12.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Analpram HC | hydrocortisone acetate and pramoxine hydrochloride | CREAM | UNAPPROVED DRUG OTHER |
| Analpram HC | hydrocortisone acetate and pramoxine hydrochloride | LOTION | ANDA |
| IMURAN | azathioprine | TABLET | NDA |
| LOTRONEX | alosetron hydrochloride | TABLET | NDA |
| LOTRONEX | alosetron hydrochloride | TABLET | NDA |
| Motofen | difenoxin and atropine sulfate | TABLET | NDA |
| Naftin | Naftifine Hydrochloride | GEL | NDA |
| Pramosone | hydrocortisone acetate and pramoxine hydrochloride | LOTION | ANDA |
| Pramosone | hydrocortisone acetate and pramoxine hydrochloride | LOTION | ANDA |
| Pramosone | hydrocortisone acetate and pramoxine hydrochloride | OINTMENT | UNAPPROVED DRUG OTHER |
| Pramosone | hydrocortisone acetate and pramoxine hydrochloride | OINTMENT | UNAPPROVED DRUG OTHER |
| RIDAURA | auranofin | CAPSULE | NDA |
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.