Details for New Drug Application (NDA): 021785

Try a free trial

See Plans and Pricing

« Back to Dashboard

NDA 021785 describes INVIRASE, which is a drug marketed by Hoffmann La Roche and Hoffmann-la Roche and is included in two NDAs. It is available from two suppliers. Additional details are available on the INVIRASE profile page.

The generic ingredient in INVIRASE is saquinavir mesylate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the saquinavir mesylate profile page.

Summary for 021785

Tradename:	INVIRASE
Applicant:	Hoffmann-la Roche
Ingredient:	saquinavir mesylate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021785

Mechanism of Action	HIV Protease Inhibitors Cytochrome P450 3A Inhibitors

Suppliers and Packaging for NDA: 021785

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INVIRASE	saquinavir mesylate	TABLET;ORAL	021785	NDA	Genentech, Inc.	0004-0244	0004-0244-51	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-0244-51)
INVIRASE	saquinavir mesylate	TABLET;ORAL	021785	NDA	State of Florida DOH Central Pharmacy	53808-0674	53808-0674-1	30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0674-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 500MG BASE
Approval Date:	Dec 17, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021785

Subscribe to access the full database, or try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann-la Roche	INVIRASE	saquinavir mesylate	TABLET;ORAL	021785-001	Dec 17, 2004	Try a Free Trial	Try a Free Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

By using our website you are consenting to our use of cookies in accordance with our privacy policy.