DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 090141
NDA 090141 describes TADALAFIL, which is a drug marketed by Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Lupin Ltd, Mylan Pharms Inc, and Teva Pharms Usa, and is included in eight NDAs. It is available from eleven 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. Twenty 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. Twenty 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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