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Last Updated: June 15, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211158


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NDA 211158 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 211158
Tradename:TIGECYCLINE
Applicant:Amneal
Ingredient:tigecycline
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 211158
Suppliers and Packaging for NDA: 211158
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIGECYCLINE tigecycline POWDER;INTRAVENOUS 211158 NDA Amneal Pharmaceuticals LLC 70121-1647 70121-1647-7 10 VIAL in 1 CARTON (70121-1647-7) > 5 mL in 1 VIAL (70121-1647-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength50MG/VIAL
Approval Date:Aug 2, 2018TE:APRLD:No
Patent:  Get Started FreePatent Expiration:Apr 7, 2033Product Flag?YSubstance Flag?Delist Request?

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