Application 214094
- Type
- NDA
- Sponsor
- BIOCRYST PHARMACEUTICALS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ORLADEYO | BEROTRALSTAT | CAPSULE; ORAL | 150MG | Yes | No |
| 002 | ORLADEYO | BEROTRALSTAT | CAPSULE; ORAL | 110MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 72769-101 | Orladeyo | Berotralstat hydrochloride | BioCryst Pharmaceuticals Inc. | NDA | Current |
| 72769-101 | Orladeyo | Berotralstat hydrochloride | BioCryst Pharmaceuticals Inc. | NDA | Current |
| 72769-102 | Orladeyo | Berotralstat hydrochloride | BioCryst Pharmaceuticals Inc. | NDA | Current |
| 72769-102 | Orladeyo | Berotralstat hydrochloride | BioCryst Pharmaceuticals Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84666 | SUPPL | 2026-01-06 |
| 84621 | SUPPL | 2025-12-31 |
| 79961 | SUPPL | 2024-10-22 |
| 79956 | SUPPL | 2024-10-22 |
| 76659 | SUPPL | 2023-11-24 |
| 76649 | SUPPL | 2023-11-22 |
| 65782 | ORIG | 2020-12-30 |
| 65570 | ORIG | 2020-12-10 |
| 65513 | ORIG | 2020-12-07 |