Details for New Drug Application (NDA): 020705

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NDA 020705 describes RESCRIPTOR, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the RESCRIPTOR profile page.

The generic ingredient in RESCRIPTOR is delavirdine mesylate. One supplier is listed for this compound. Additional details are available on the delavirdine mesylate profile page.

Summary for 020705

Tradename:	RESCRIPTOR
Applicant:	Viiv Hlthcare
Ingredient:	delavirdine mesylate
Patents:	1
Formulation / Manufacturing:	see details

Generic Entry Opportunity Date for 020705

Generic Entry Date for 020705^: ➤ Sign Up* Constraining patent/regulatory exclusivity: ➤ Sign Up Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 020705

Ingredient-type	Non-Nucleoside Analog
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 020705

Anti-HIV Agents
Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 020705

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RESCRIPTOR	delavirdine mesylate	TABLET;ORAL	020705	NDA	ViiV Healthcare Company	49702-209	49702-209-24	360 TABLET in 1 BOTTLE (49702-209-24)
RESCRIPTOR	delavirdine mesylate	TABLET;ORAL	020705	NDA	ViiV Healthcare Company	49702-225	49702-225-17	180 TABLET in 1 BOTTLE (49702-225-17)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Apr 4, 1997	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jul 14, 1999	TE:		RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Jun 7, 2019	Product Flag?		Substance Flag?		Delist Request?

Expired US Patents for NDA 020705

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	RESCRIPTOR	delavirdine mesylate	TABLET;ORAL	020705-001	Apr 4, 1997	➤ Sign Up	➤ Sign Up
Viiv Hlthcare	RESCRIPTOR	delavirdine mesylate	TABLET;ORAL	020705-002	Jul 14, 1999	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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