Register entry
- Registered sites
- 0
- Active NDC listings
- 11
- Live patents
- 1
- Countries
- 0
Catalogue
Drug listings by form and route
1111 active NDC listings: 11 human prescription drug. By marketing category: NDA 6, UNAPPROVED DRUG OTHER 3, ANDA 2.
| Dosage form | NDCs |
|---|---|
| tablet | 4 |
| lotion | 2 |
| ointment | 2 |
| capsule | 1 |
| cream | 1 |
| gel | 1 |
| Route | NDCs |
|---|---|
| topical | 6 |
| oral | 5 |
| Labeller name on the listing | NDCs |
|---|---|
| sebela pharmaceuticals inc. | 11 |
Exclusivity
Patents and exclusivities
1| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8486456 | ONMELitraconazole | product | Oct 2028 |
Catalogue
Marketed products
12Showing 11 of 12.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Analpram HC | hydrocortisone acetate and pramoxine hydrochloride | cream, topical | 54766-799UNAPPROVED DRUG OTHER |
| Analpram HC | hydrocortisone acetate and pramoxine hydrochloride | lotion, topical | 54766-829ANDA |
| IMURAN | azathioprine | tablet, oral | 54766-590NDA |
| LOTRONEX | alosetron hydrochloride | tablet, oral | 54766-894NDA |
| LOTRONEX | alosetron hydrochloride | tablet, oral | 54766-895NDA |
| Motofen | difenoxin and atropine sulfate | tablet, oral | 54766-200NDA |
| Naftin | Naftifine Hydrochloride | gel, topical | 54766-772NDA |
| Pramosone | hydrocortisone acetate and pramoxine hydrochloride | lotion, topical | 54766-729ANDA |
| Pramosone | hydrocortisone acetate and pramoxine hydrochloride | ointment, topical | 54766-763UNAPPROVED DRUG OTHER |
| Pramosone | hydrocortisone acetate and pramoxine hydrochloride | ointment, topical | 54766-777UNAPPROVED DRUG OTHER |
| RIDAURA | auranofin | capsule, oral | 54766-093NDA |
Compare
Other companies listing hydrocortisone acetate and pramoxine hydrochloride
- Legacy Pharma USA Inc.1 site · 29 NDC
Enquiry
Common questions
- Is Sebela Pharmaceuticals Inc. FDA approved?
- Sebela Pharmaceuticals Inc. holds no registered establishment of its own; 12 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does Sebela Pharmaceuticals Inc. make?
- 12 products are listed under Sebela Pharmaceuticals Inc. in the openFDA NDC Directory, most often as tablet; lotion; ointment. 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.