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Details for New Drug Application (NDA): 020180
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The generic ingredient in PROSCAR is finasteride. There are fourteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the finasteride profile page.
Summary for 020180
Tradename: | PROSCAR |
Applicant: | Merck |
Ingredient: | finasteride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020180
Mechanism of Action | 5-alpha Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 020180
Suppliers and Packaging for NDA: 020180
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROSCAR | finasteride | TABLET;ORAL | 020180 | NDA | Merck Sharp & Dohme Corp. | 0006-0072 | 0006-0072-31 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-0072-31) |
PROSCAR | finasteride | TABLET;ORAL | 020180 | NDA | Merck Sharp & Dohme Corp. | 0006-0072 | 0006-0072-58 | 100 TABLET, FILM COATED in 1 BOTTLE (0006-0072-58) |
Paragraph IV (Patent) Challenges for 020180
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
PROSCAR | TABLET;ORAL | finasteride | 020180 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jun 19, 1992 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020180
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | Start Trial | Start Trial |
Merck | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | Start Trial | Start Trial |
Merck | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | Start Trial | Start Trial |
Merck | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | Start Trial | Start Trial |
Merck | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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