Details for New Drug Application (NDA): 209266
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NDA 209266 describes AVANAFIL, which is a drug marketed by Hetero Labs Ltd V and is included in one NDA. It is available from one supplier. Additional details are available on the AVANAFIL profile page.
The generic ingredient in AVANAFIL is avanafil. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the avanafil profile page.
The generic ingredient in AVANAFIL is avanafil. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the avanafil profile page.
Summary for 209266
| Tradename: | AVANAFIL |
| Applicant: | Hetero Labs Ltd V |
| Ingredient: | avanafil |
| Patents: | 0 |
Pharmacology for NDA: 209266
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Suppliers and Packaging for NDA: 209266
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AVANAFIL | avanafil | TABLET;ORAL | 209266 | ANDA | Camber Pharmaceuticals, Inc. | 31722-440 | 31722-440-01 | 100 TABLET in 1 BOTTLE (31722-440-01) |
| AVANAFIL | avanafil | TABLET;ORAL | 209266 | ANDA | Camber Pharmaceuticals, Inc. | 31722-440 | 31722-440-30 | 30 TABLET in 1 BOTTLE (31722-440-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jun 14, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jun 14, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Jun 14, 2024 | TE: | AB | RLD: | No | ||||
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