Details for New Drug Application (NDA): 208934
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NDA 208934 describes TADALAFIL, which is a drug marketed by Accord Hlthcare, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Austarpharma, Chartwell Rx, Cipla, Dr Reddys, Hetero Labs Ltd Iii, Lupin Ltd, Macleods Pharms Ltd, Mylan, 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 thirty-nine NDAs. It is available from forty-four 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for 208934
| Tradename: | TADALAFIL |
| Applicant: | Sun Pharm |
| Ingredient: | tadalafil |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208934
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 208934
Suppliers and Packaging for NDA: 208934
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TADALAFIL | tadalafil | TABLET;ORAL | 208934 | ANDA | NorthStar RxLLC | 16714-074 | 16714-074-02 | 2 BLISTER PACK in 1 CARTON (16714-074-02) / 15 TABLET, FILM COATED in 1 BLISTER PACK (16714-074-01) |
| TADALAFIL | tadalafil | TABLET;ORAL | 208934 | ANDA | NorthStar RxLLC | 16714-075 | 16714-075-01 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-075-01) |
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: | Mar 26, 2019 | TE: | AB1 | RLD: | No | ||||
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