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Last Updated: June 15, 2021

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Details for New Drug Application (NDA): 205722


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NDA 205722 describes TIGECYCLINE, which is a drug marketed by Accord Hlthcare Inc, Amneal, Apotex, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Sandoz Inc, and Xellia Pharms Aps, and is included in seven NDAs. It is available from seven 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. Eight suppliers are listed for this compound. Additional details are available on the tigecycline profile page.
Summary for 205722
Tradename:TIGECYCLINE
Applicant:Xellia Pharms Aps
Ingredient:tigecycline
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205722
Suppliers and Packaging for NDA: 205722
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIGECYCLINE tigecycline POWDER;INTRAVENOUS 205722 ANDA Xellia Pharmaceuticals USA LLC 70594-035 70594-035-02 10 VIAL, GLASS in 1 CARTON (70594-035-02) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70594-035-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength50MG/VIAL
Approval Date:Oct 18, 2019TE:APRLD:No

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