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Details for New Drug Application (NDA): 022110
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.
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 022110
| Tradename: | VIBATIV |
| Applicant: | Theravance Biopharma |
| Ingredient: | telavancin hydrochloride |
| Patents: | 11 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 022110
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 022110
| Ingredient-type | Lipoglycopeptides |
Suppliers and Packaging for NDA: 022110
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIBATIV | telavancin hydrochloride | POWDER;INTRAVENOUS | 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;INTRAVENOUS | 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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 250MG BASE/VIAL | ||||
| Approval Date: | Sep 11, 2009 | TE: | RLD: | Yes | |||||
| Patent: | ➤ Sign Up | Patent Expiration: | Sep 11, 2023 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD FOR TREATING BACTERIAL INFECTION | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Aug 24, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ➤ Sign Up | Patent Expiration: | Jun 5, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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