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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 206335

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NDA 206335 describes TIGECYCLINE, which is a drug marketed by Accord Hlthcare Inc, Amneal, Apotex, Eugia Pharma, Fresenius Kabi Usa, Meitheal, Sandoz, and Xellia Pharms Aps, and is included in eight NDAs. It is available from six suppliers. There is one patent protecting this drug. Additional details are available on the TIGECYCLINE profile page.

The generic ingredient in TIGECYCLINE 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 206335

Tradename:	TIGECYCLINE
Applicant:	Eugia Pharma
Ingredient:	tigecycline
Patents:	0

Pharmacology for NDA: 206335

Suppliers and Packaging for NDA: 206335

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	206335	ANDA	Eugia US LLC	55150-228	55150-228-10	10 VIAL, SINGLE-DOSE in 1 CARTON (55150-228-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Jun 11, 2019	TE:	AP	RLD:	No

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