Details for New Drug Application (NDA): 021821

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NDA 021821 describes TYGACIL, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TYGACIL profile page.

The generic ingredient in TYGACIL is tigecycline. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tigecycline profile page.

Summary for 021821

Tradename:	TYGACIL
Applicant:	Pf Prism Cv
Ingredient:	tigecycline
Patents:	6

Pharmacology for NDA: 021821

Suppliers and Packaging for NDA: 021821

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-4990	0008-4990-20	10 VIAL, SINGLE-USE in 1 CARTON (0008-4990-20) / 50 mL in 1 VIAL, SINGLE-USE (0008-4990-19)
TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-4994	0008-4994-20	10 VIAL, SINGLE-USE in 1 CARTON (0008-4994-20) / 50 mL in 1 VIAL, SINGLE-USE (0008-4994-19)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Jun 15, 2005	TE:	AP	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 13, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Feb 5, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Oct 8, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021821

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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