Details for New Drug Application (NDA): 210255
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The generic ingredient in TADALAFIL is tadalafil. There are twenty-five drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Pharmacology for NDA: 210255
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 210255
Suppliers and Packaging for NDA: 210255
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TADALAFIL | tadalafil | TABLET;ORAL | 210255 | ANDA | Cipla USA Inc. | 69097-526 | 69097-526-03 | 60 TABLET, FILM COATED in 1 BOTTLE (69097-526-03) |
TADALAFIL | tadalafil | TABLET;ORAL | 210255 | ANDA | Cipla USA Inc. | 69097-526 | 69097-526-16 | 4 TABLET, FILM COATED in 1 CARTON (69097-526-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Feb 5, 2019 | TE: | AB2 | RLD: | No |
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