Last Updated: September 24, 2026

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, Eugia Pharma, Fresenius Kabi Usa, Meitheal, Sandoz, and Xellia Pharms Aps, and is included in eight NDAs. It is available from five 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 is one drug master file entry for this compound. Six 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

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:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Aug 2, 2018	TE:	AP	RLD:	No
Patent:	⤷ Start Trial	Patent Expiration:	Apr 7, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

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