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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 Cumberland Pharms and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the VIBATIV profile page.
The generic ingredient in VIBATIV is telavancin hydrochloride. One supplier is listed for this compound. Additional details are available on the telavancin hydrochloride profile page.
The generic ingredient in VIBATIV is telavancin hydrochloride. One supplier is listed for this compound. Additional details are available on the telavancin hydrochloride profile page.
Summary for 022110
| Tradename: | VIBATIV |
| Applicant: | Cumberland Pharms |
| Ingredient: | telavancin hydrochloride |
| Patents: | 11 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 022110
Generic Entry Date for 022110*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;IV (INFUSION) |
*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
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 Biopharma R&D, Inc. | 62847-001 | 62847-001-01 | 1 VIAL, SINGLE-USE in 1 CONTAINER (62847-001-01) > 50 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: | Start Trial | Patent Expiration: | Sep 11, 2023 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD FOR TREATING BACTERIAL INFECTION | ||||||||
| Patent: | Start Trial | Patent Expiration: | Aug 24, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Jun 5, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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