Details for New Drug Application (NDA): 021896

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NDA 021896 describes EMTRIVA, which is a drug marketed by Gilead and is included in two NDAs. It is available from one supplier. Additional details are available on the EMTRIVA profile page.

The generic ingredient in EMTRIVA is emtricitabine. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the emtricitabine profile page.

Summary for 021896

Tradename:	EMTRIVA
Applicant:	Gilead
Ingredient:	emtricitabine
Patents:	0

Pharmacology for NDA: 021896

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 021896

Anti-HIV Agents
Antiviral Agents
Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 021896

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EMTRIVA	emtricitabine	SOLUTION;ORAL	021896	NDA	Gilead Sciences, Inc.	61958-0602	61958-0602-1	1 BOTTLE, DISPENSING in 1 CARTON (61958-0602-1) / 170 mL in 1 BOTTLE, DISPENSING

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Sep 28, 2005	TE:		RLD:	Yes

Expired US Patents for NDA 021896

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005	6,703,396*PED	⤷ Get Started Free
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005	5,210,085*PED	⤷ Get Started Free
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005	6,642,245*PED	⤷ Get Started Free
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005	5,914,331*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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