Details for New Drug Application (NDA): 200327

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NDA 200327 describes TEFLARO, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TEFLARO profile page.

The generic ingredient in TEFLARO is ceftaroline fosamil. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ceftaroline fosamil profile page.

Summary for 200327

Tradename:	TEFLARO
Applicant:	Abbvie
Ingredient:	ceftaroline fosamil
Patents:	2

Pharmacology for NDA: 200327

Suppliers and Packaging for NDA: 200327

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327	NDA	Allergan, Inc.	0456-0400	0456-0400-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01)
TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327	NDA	Allergan, Inc.	0456-0600	0456-0600-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0600-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	400MG/VIAL
Approval Date:	Oct 29, 2010	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 10, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING BACTERIAL INFECTIONS
Patent:	⤷ Sign Up	Patent Expiration:	Sep 21, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	600MG/VIAL
Approval Date:	Oct 29, 2010	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 10, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING BACTERIAL INFECTIONS

Expired US Patents for NDA 200327

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010	⤷ Sign Up	⤷ Sign Up
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010	⤷ Sign Up	⤷ Sign Up
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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