Details for New Drug Application (NDA): 217606
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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 217606
Tradename: | TADALAFIL |
Applicant: | Hibrow Hlthcare |
Ingredient: | tadalafil |
Patents: | 0 |
Pharmacology for NDA: 217606
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 217606
Suppliers and Packaging for NDA: 217606
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TADALAFIL | tadalafil | TABLET;ORAL | 217606 | ANDA | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | 82968-001 | 82968-001-03 | 2 BLISTER PACK in 1 CARTON (82968-001-03) / 15 TABLET, FILM COATED in 1 BLISTER PACK |
TADALAFIL | tadalafil | TABLET;ORAL | 217606 | ANDA | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | 82968-002 | 82968-002-01 | 30 TABLET, FILM COATED in 1 BOTTLE (82968-002-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Aug 13, 2024 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Aug 13, 2024 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 13, 2024 | TE: | AB1 | RLD: | No |
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