Details for New Drug Application (NDA): 210145
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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 210145
Tradename: | TADALAFIL |
Applicant: | Dr Reddys |
Ingredient: | tadalafil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210145
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 210145
Suppliers and Packaging for NDA: 210145
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TADALAFIL | tadalafil | TABLET;ORAL | 210145 | ANDA | Dr.Reddys Laboratories Inc | 43598-578 | 43598-578-30 | 30 TABLET, FILM COATED in 1 BOTTLE (43598-578-30) |
TADALAFIL | tadalafil | TABLET;ORAL | 210145 | ANDA | Dr.Reddys Laboratories Inc | 43598-578 | 43598-578-60 | 60 TABLET, FILM COATED in 1 BOTTLE (43598-578-60) |
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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