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Last Updated: June 18, 2024

Details for New Drug Application (NDA): 020788


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NDA 020788 describes PROPECIA, which is a drug marketed by Organon and is included in one NDA. It is available from one supplier. Additional details are available on the PROPECIA profile page.

The generic ingredient in PROPECIA is finasteride. There are fourteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the finasteride profile page.
Summary for 020788
Tradename:PROPECIA
Applicant:Organon
Ingredient:finasteride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020788
Mechanism of Action5-alpha Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 020788
Suppliers and Packaging for NDA: 020788
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPECIA finasteride TABLET;ORAL 020788 NDA Organon LLC 78206-152 78206-152-01 30 TABLET, FILM COATED in 1 BOTTLE (78206-152-01)
PROPECIA finasteride TABLET;ORAL 020788 NDA Organon LLC 78206-152 78206-152-02 90 TABLET, FILM COATED in 1 BOTTLE (78206-152-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Dec 19, 1997TE:ABRLD:Yes

Expired US Patents for NDA 020788

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon PROPECIA finasteride TABLET;ORAL 020788-001 Dec 19, 1997 ⤷  Sign Up ⤷  Sign Up
Organon PROPECIA finasteride TABLET;ORAL 020788-001 Dec 19, 1997 ⤷  Sign Up ⤷  Sign Up
Organon PROPECIA finasteride TABLET;ORAL 020788-001 Dec 19, 1997 ⤷  Sign Up ⤷  Sign Up
Organon PROPECIA finasteride TABLET;ORAL 020788-001 Dec 19, 1997 ⤷  Sign Up ⤷  Sign Up
Organon PROPECIA finasteride TABLET;ORAL 020788-001 Dec 19, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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