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Details for New Drug Application (NDA): 022110

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NDA 022110 describes VIBATIV, which is a drug marketed by Theravance Biopharma and is included in one NDA. It is available from two suppliers. There are eleven patents protecting this drug. Additional details are available on the VIBATIV profile page.

The generic ingredient in VIBATIV is telavancin hydrochloride. Two suppliers are listed for this compound. Additional details are available on the telavancin hydrochloride profile page.

Summary for NDA: 022110

Tradename:
VIBATIV
Applicant:
Theravance Biopharma
Ingredient:
telavancin hydrochloride
Patents:11
Formulation / Manufacturing:see details

Pharmacology for NDA: 022110

Ingredient-typeLipoglycopeptides

Suppliers and Packaging for NDA: 022110

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIBATIV
telavancin hydrochloride
POWDER;IV (INFUSION) 022110 NDA Theravance, Inc. 52118-001 52118-001-01 1 VIAL, SINGLE-USE in 1 CONTAINER (52118-001-01) > 50 mL in 1 VIAL, SINGLE-USE
VIBATIV
telavancin hydrochloride
POWDER;IV (INFUSION) 022110 NDA Theravance, Inc. 52118-002 52118-002-01 1 VIAL, SINGLE-USE in 1 CONTAINER (52118-002-01) > 17 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)StrengthEQ 250MG BASE/VIAL
Approval Date:Sep 11, 2009TE:RLD:No
Patent:6,858,584Patent Expiration:Aug 24, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:6,872,701Patent Expiration:Jun 5, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:7,208,471Patent Expiration:May 1, 2021Product Flag?YSubstance Flag?YDelist Request?


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