FdaApplication
ANDA 207314
Identifiers
- fda_app_no: ANDA207314
Properties
| Property | Value |
|---|---|
| applicant_name | MACLEODS PHARMACEUTICALS LTD |
| application_type | ANDA |
| approval_date | 2024-07-22 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL |
2 products