Details for New Drug Application (NDA): 209167
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NDA 209167 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, Hangzhou Binjiang, Hetero Labs Ltd Iii, Hibrow Hlthcare, Lupin Ltd, Macleods Pharms Ltd, Norvium Bioscience, Novitium Pharma, 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-five 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for 209167
| Tradename: | TADALAFIL |
| Applicant: | Accord Hlthcare |
| Ingredient: | tadalafil |
| Patents: | 0 |
Pharmacology for NDA: 209167
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 209167
Suppliers and Packaging for NDA: 209167
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TADALAFIL | tadalafil | TABLET;ORAL | 209167 | ANDA | Accord Healthcare Inc. | 16729-369 | 16729-369-10 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-369-10) |
| TADALAFIL | tadalafil | TABLET;ORAL | 209167 | ANDA | Accord Healthcare Inc. | 16729-369 | 16729-369-16 | 500 TABLET, FILM COATED in 1 BOTTLE (16729-369-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Mar 26, 2019 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Mar 26, 2019 | TE: | AB1 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 23, 2019 | TE: | AB1 | RLD: | No | ||||
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