Details for New Drug Application (NDA): 209250
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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.
Pharmacology for NDA: 209250
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 209250
Suppliers and Packaging for NDA: 209250
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TADALAFIL | tadalafil | TABLET;ORAL | 209250 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-286 | 29300-286-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-286-01) |
TADALAFIL | tadalafil | TABLET;ORAL | 209250 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-286 | 29300-286-05 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-286-05) |
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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