Details for New Drug Application (NDA): 203687
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The generic ingredient in FINASTERIDE is finasteride; tadalafil. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the finasteride; tadalafil profile page.
Summary for 203687
Tradename: | FINASTERIDE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | finasteride |
Patents: | 0 |
Pharmacology for NDA: 203687
Mechanism of Action | 5-alpha Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 203687
Suppliers and Packaging for NDA: 203687
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FINASTERIDE | finasteride | TABLET;ORAL | 203687 | ANDA | Burel Pharmaceuticals, LLC | 35573-400 | 35573-400-99 | 1000 TABLET, FILM COATED in 1 BOTTLE (35573-400-99) |
FINASTERIDE | finasteride | TABLET;ORAL | 203687 | ANDA | Rising Pharma Holdings, Inc. | 57237-061 | 57237-061-30 | 30 TABLET, FILM COATED in 1 BOTTLE (57237-061-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Nov 5, 2013 | TE: | AB | RLD: | No |
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