Details for New Drug Application (NDA): 209654
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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.
Summary for 209654
Tradename: | TADALAFIL |
Applicant: | Ajanta Pharma Ltd |
Ingredient: | tadalafil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209654
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 209654
Suppliers and Packaging for NDA: 209654
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TADALAFIL | tadalafil | TABLET;ORAL | 209654 | ANDA | Ajanta Pharma USA Inc. | 27241-111 | 27241-111-03 | 30 TABLET in 1 BOTTLE (27241-111-03) |
TADALAFIL | tadalafil | TABLET;ORAL | 209654 | ANDA | Ajanta Pharma USA Inc. | 27241-111 | 27241-111-05 | 500 TABLET in 1 BOTTLE (27241-111-05) |
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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