Details for New Drug Application (NDA): 076437
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The generic ingredient in FINASTERIDE is finasteride. There are fourteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the finasteride profile page.
Summary for 076437
Tradename: | FINASTERIDE |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | finasteride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076437
Mechanism of Action | 5-alpha Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 076437
Suppliers and Packaging for NDA: 076437
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FINASTERIDE | finasteride | TABLET;ORAL | 076437 | ANDA | Dr. Reddy's Laboratories Limited | 55111-172 | 55111-172-01 | 100 TABLET in 1 BOTTLE (55111-172-01) |
FINASTERIDE | finasteride | TABLET;ORAL | 076437 | ANDA | Dr. Reddy's Laboratories Limited | 55111-172 | 55111-172-05 | 500 TABLET in 1 BOTTLE (55111-172-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Feb 28, 2007 | TE: | AB | RLD: | No |
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