Details for New Drug Application (NDA): 211298
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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 211298
Tradename: | TADALAFIL |
Applicant: | Umedica |
Ingredient: | tadalafil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211298
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 211298
Suppliers and Packaging for NDA: 211298
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TADALAFIL | tadalafil | TABLET;ORAL | 211298 | ANDA | NIVAGEN PHARMACEUTICALS, INC. | 75834-247 | 75834-247-01 | 1000 TABLET, FILM COATED in 1 BOTTLE (75834-247-01) |
TADALAFIL | tadalafil | TABLET;ORAL | 211298 | ANDA | NIVAGEN PHARMACEUTICALS, INC. | 75834-247 | 75834-247-15 | 30 TABLET, FILM COATED in 1 BLISTER PACK (75834-247-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Oct 23, 2020 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Oct 23, 2020 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Oct 23, 2020 | TE: | AB1 | RLD: | No |
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