Details for New Drug Application (NDA): 020180

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NDA 020180 describes PROSCAR, 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 PROSCAR profile page.

The generic ingredient in PROSCAR is finasteride. There are fourteen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the finasteride profile page.

Summary for 020180

Tradename:	PROSCAR
Applicant:	Organon
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

5-alpha Reductase Inhibitors
Urological Agents

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	Organon LLC	78206-153	78206-153-01	30 TABLET, FILM COATED in 1 BOTTLE (78206-153-01)
PROSCAR	finasteride	TABLET;ORAL	020180	NDA	Organon LLC	78206-153	78206-153-02	100 TABLET, FILM COATED in 1 BOTTLE (78206-153-02)

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	⤷ Try a Trial	⤷ Try a Trial
Organon	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	⤷ Try a Trial	⤷ Try a Trial
Organon	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	⤷ Try a Trial	⤷ Try a Trial
Organon	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	⤷ Try a Trial	⤷ Try a Trial
Organon	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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