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Details for New Drug Application (NDA): 020180
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NDA 020180 describes PROSCAR, which is a drug marketed by Merck and is included in one NDA. It is available from one supplier. Additional details are available on the PROSCAR profile page.
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.
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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