Details for New Drug Application (NDA): 021500

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NDA 021500 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 021500

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

Pharmacology for NDA: 021500

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 021500

Anti-HIV Agents
Antiviral Agents
Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 021500

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EMTRIVA	emtricitabine	CAPSULE;ORAL	021500	NDA	Gilead Sciences, Inc.	61958-0601	61958-0601-1	30 CAPSULE in 1 BOTTLE, PLASTIC (61958-0601-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Jul 2, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021500

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003	6,703,396*PED	⤷ Get Started Free
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003	5,210,085*PED	⤷ Get Started Free
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003	7,402,588*PED	⤷ Get Started Free
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003	6,642,245*PED	⤷ Get Started Free
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003	5,914,331*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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