Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 218232
Company: ZYDUS LIFESCIENCES
Company: ZYDUS LIFESCIENCES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FINASTERIDE AND TADALAFIL | FINASTERIDE; TADALAFIL | 5MG;5MG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/15/2024 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218232Orig1s000ltr.pdf |
FINASTERIDE AND TADALAFIL
CAPSULE;ORAL; 5MG;5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENTADFI | FINASTERIDE; TADALAFIL | 5MG;5MG | CAPSULE;ORAL | Prescription | Yes | AB | 215423 | BLUE WATER BIOTECH |
| FINASTERIDE AND TADALAFIL | FINASTERIDE; TADALAFIL | 5MG;5MG | CAPSULE;ORAL | Prescription | No | AB | 218232 | ZYDUS LIFESCIENCES |