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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 091620

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NDA 091620 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 091620

Tradename:	TIGECYCLINE
Applicant:	Sandoz
Ingredient:	tigecycline
Patents:	0

Pharmacology for NDA: 091620

Suppliers and Packaging for NDA: 091620

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	091620	ANDA	Sandoz Inc	0781-3481	0781-3481-92	10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3481-92) / 10 mL in 1 VIAL, SINGLE-DOSE (0781-3481-70)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	May 27, 2015	TE:	AP	RLD:	No

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