Details for New Drug Application (NDA): 217606
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NDA 217606 describes TADALAFIL, which is a drug marketed by Accord Hlthcare, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Dr Reddys, Fourrts Labs, Hangzhou Binjiang, Hetero Labs Ltd Iii, Lupin Ltd, Macleods Pharms Ltd, Norvium Bioscience, Novitium Pharma, Pharmobedient, Prinston Inc, Qilu Pharm Hainan, Rising, Shandong, Sun Pharm, Sunshine, Teva Pharms Usa, Torrent, Umedica, Unichem, Vkt Pharma, Watson Labs Inc, and Zydus Pharms, and is included in forty NDAs. It is available from forty-six suppliers. Additional details are available on the TADALAFIL profile page.
The generic ingredient in TADALAFIL is tadalafil. There are twenty-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
The generic ingredient in TADALAFIL is tadalafil. There are twenty-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for 217606
| Tradename: | TADALAFIL |
| Applicant: | Fourrts Labs |
| Ingredient: | tadalafil |
| Patents: | 0 |
Pharmacology for NDA: 217606
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 217606
Suppliers and Packaging for NDA: 217606
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TADALAFIL | tadalafil | TABLET;ORAL | 217606 | ANDA | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | 82968-001 | 82968-001-03 | 2 BLISTER PACK in 1 CARTON (82968-001-03) / 15 TABLET, FILM COATED in 1 BLISTER PACK |
| TADALAFIL | tadalafil | TABLET;ORAL | 217606 | ANDA | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | 82968-002 | 82968-002-01 | 30 TABLET, FILM COATED in 1 BOTTLE (82968-002-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Aug 13, 2024 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Aug 13, 2024 | TE: | AB1 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 13, 2024 | TE: | AB1 | RLD: | No | ||||
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