Skip to contentApplication 206709
- Type
- NDA
- Sponsor
- BIOCODEX SA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DIACOMIT | STIRIPENTOL | CAPSULE;ORAL | 250MG | Yes | No |
| 002 | DIACOMIT | STIRIPENTOL | CAPSULE;ORAL | 500MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68418-7939 | Diacomit | stiripentol | BIOCODEX, INC. | NDA | Current |
| 68418-7939 | Diacomit | stiripentol | BIOCODEX, INC. | NDA | Current |
| 68418-7939 | Diacomit | stiripentol | BIOCODEX INC. | NDA | Current |
| 68418-7939 | Diacomit | stiripentol | BIOCODEX, INC. | NDA | Current |
| 68418-7940 | Diacomit | stiripentol | BIOCODEX, INC. | NDA | Current |
| 68418-7940 | Diacomit | stiripentol | BIOCODEX, INC. | NDA | Current |
| 68418-7940 | Diacomit | stiripentol | BIOCODEX INC. | NDA | Current |
| 68418-7940 | Diacomit | stiripentol | BIOCODEX, INC. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85707 | SUPPL | 2026-04-17 |
| 85708 | SUPPL | 2026-04-16 |
| 85698 | SUPPL | 2026-04-16 |
| 71563 | SUPPL | 2022-07-15 |
| 71548 | SUPPL | 2022-07-14 |
| 71547 | SUPPL | 2022-07-14 |
| 55461 | ORIG | 2018-09-12 |
| 55327 | ORIG | 2018-08-27 |
| 55251 | ORIG | 2018-08-21 |
| 55250 | ORIG | 2018-08-21 |