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Details for New Drug Application (NDA): 090141
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NDA 090141 describes TADALAFIL, which is a drug marketed by Accord Hlthcare, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms Co, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Lupin Ltd, Macleods Pharms Ltd, Mylan, Qilu Pharm Co Ltd, Sun Pharm, Sunshine Lake, Teva Pharms Usa, Torrent, Unichem Labs Ltd, Watson Labs Inc, and Zydus Pharms, and is included in twenty-nine NDAs. It is available from thirty-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. Thirty-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. Thirty-eight suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for 090141
| Tradename: | TADALAFIL |
| Applicant: | Teva Pharms Usa |
| Ingredient: | tadalafil |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090141
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 090141
Suppliers and Packaging for NDA: 090141
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TADALAFIL | tadalafil | TABLET;ORAL | 090141 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3016 | 0093-3016-65 | 2 BLISTER PACK in 1 BOX (0093-3016-65) > 15 TABLET, FILM COATED in 1 BLISTER PACK (0093-3016-30) |
| TADALAFIL | tadalafil | TABLET;ORAL | 090141 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3017 | 0093-3017-56 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-3017-56) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | May 22, 2018 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 26, 2019 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | May 22, 2018 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 26, 2019 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 22, 2018 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 26, 2019 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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