Details for New Drug Application (NDA): 208910
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NDA 208910 describes FIRVANQ KIT, which is a drug marketed by Azurity and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug. Additional details are available on the FIRVANQ KIT profile page.
The generic ingredient in FIRVANQ KIT is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
The generic ingredient in FIRVANQ KIT is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 208910
| Tradename: | FIRVANQ KIT |
| Applicant: | Azurity |
| Ingredient: | vancomycin hydrochloride |
| Patents: | 7 |
Medical Subject Heading (MeSH) Categories for 208910
Suppliers and Packaging for NDA: 208910
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FIRVANQ KIT | vancomycin hydrochloride | FOR SOLUTION;ORAL | 208910 | NDA AUTHORIZED GENERIC | Wilshire Pharmaceuticals, Inc. | 52536-104 | 52536-104-05 | 1 KIT in 1 CARTON (52536-104-05) * 3.75 g in 1 BOTTLE (52536-094-05) * 147 mL in 1 BOTTLE (52536-084-05) |
| FIRVANQ KIT | vancomycin hydrochloride | FOR SOLUTION;ORAL | 208910 | NDA AUTHORIZED GENERIC | Wilshire Pharmaceuticals, Inc. | 52536-106 | 52536-106-05 | 1 KIT in 1 CARTON (52536-106-05) * 7.5 g in 1 BOTTLE (52536-096-05) * 145 mL in 1 BOTTLE (52536-086-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 25MG BASE/ML | ||||
| Approval Date: | Jan 26, 2018 | TE: | AB | RLD: | Yes | ||||
| Patent: | 10,493,028 | Patent Expiration: | Mar 13, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,688,046 | Patent Expiration: | Mar 13, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,959,946 | Patent Expiration: | Mar 13, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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