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-two 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

Pharmacology for NDA: 020788

Mechanism of Action	5-alpha Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 020788

5-alpha Reductase Inhibitors
Urological Agents

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:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Dec 19, 1997	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020788

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	4,377,584	⤷ Get Started Free
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	5,886,184	⤷ Get Started Free
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	5,571,817	⤷ Get Started Free
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	4,760,071	⤷ Get Started Free
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	5,547,957	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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