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Details for New Drug Application (NDA): 090141
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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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