Application 210910
- Type
- NDA
- Sponsor
- REDHILL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AEMCOLO | RIFAMYCIN SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 194MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N210910-001 | AEMCOLO | RIFAMYCIN SODIUM | EQ 194MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2018-11-16 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N210910-001 | NCE | 2023-11-16 |
| N210910-001 | GAIN | 2028-11-16 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 57841-1200 | Aemcolo | Rifamycin | RedHill Biopharma Ltd | NDA | Current |
| 57841-1200 | Aemcolo | Rifamycin | RedHill Biopharma Ltd | NDA | Current |
| 57841-1201 | Aemcolo | Rifamycin | RedHill Biopharma Ltd | NDA | Current |
| 57841-1201 | Aemcolo | Rifamycin | RedHill Biopharma Ltd | NDA | Current |
| 71068-001 | Aemcolo | Rifamycin | Aries Pharmaceuticals Inc | NDA | Current |
| 71068-001 | Aemcolo | Rifamycin | Aries Pharmaceuticals Inc | NDA | Current |
| 71068-001 | Aemcolo | Rifamycin | Aries Pharmaceuticals Inc | NDA | Current |