Application 213981
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BOSENTAN | BOSENTAN | TABLET, FOR SUSPENSION;ORAL | 32MG | No | No |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A213981-001 | BOSENTAN | BOSENTAN | 32MG | TABLET, FOR SUSPENSION / ORAL | AB | | 2026-02-17 |
Therapeutic equivalence codes#
Application-product, TE code table| Application-product | TE code |
|---|
| A213981-001 | AB |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.