Details for New Drug Application (NDA): 215423
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NDA 215423 describes ENTADFI, which is a drug marketed by Blue Water Biotech and is included in one NDA. It is available from one supplier. Additional details are available on the ENTADFI profile page.
The generic ingredient in ENTADFI is finasteride; tadalafil. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the finasteride; tadalafil profile page.
The generic ingredient in ENTADFI is finasteride; tadalafil. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the finasteride; tadalafil profile page.
Summary for 215423
| Tradename: | ENTADFI |
| Applicant: | Blue Water Biotech |
| Ingredient: | finasteride; tadalafil |
| Patents: | 0 |
Pharmacology for NDA: 215423
| Mechanism of Action | 5-alpha Reductase Inhibitors Phosphodiesterase 5 Inhibitors |
Suppliers and Packaging for NDA: 215423
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENTADFI | finasteride; tadalafil | CAPSULE;ORAL | 215423 | NDA | Veru Inc. | 69681-125 | 69681-125-30 | 30 CAPSULE in 1 BOTTLE (69681-125-30) |
| ENTADFI | finasteride; tadalafil | CAPSULE;ORAL | 215423 | NDA | Veru Inc. | 69681-125 | 69681-125-90 | 90 CAPSULE in 1 BOTTLE (69681-125-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 5MG;5MG | ||||
| Approval Date: | Dec 9, 2021 | TE: | RLD: | Yes | |||||
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