FdaApplication
ANDA 216432
Identifiers
- fda_app_no: ANDA216432
Properties
| Property | Value |
|---|---|
| applicant_name | TP ANDA HOLDINGS LLC |
| application_type | ANDA |
| approval_date | 2025-09-03 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | 100MG/PACKET | FOR SOLUTION;ORAL |
| SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | 500MG/PACKET | FOR SOLUTION;ORAL |
2 products