Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215423
Company: BLUE WATER BIOTECH
Company: BLUE WATER BIOTECH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENTADFI | FINASTERIDE; TADALAFIL | 5MG;5MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/09/2021 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215423s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215423Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215423Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/09/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215423s000lbl.pdf |
ENTADFI
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 |