Details for New Drug Application (NDA): 209481
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The generic ingredient in VANCOMYCIN HYDROCHLORIDE 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 209481
Tradename: | VANCOMYCIN HYDROCHLORIDE |
Applicant: | Mylan Labs Ltd |
Ingredient: | vancomycin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 209481
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | POWDER;INTRAVENOUS | 209481 | NDA | Mylan Institutional LLC | 67457-705 | 67457-705-75 | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-705-75) / 15 mL in 1 VIAL, SINGLE-DOSE (67457-705-00) |
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | POWDER;INTRAVENOUS | 209481 | NDA | Mylan Institutional LLC | 67457-823 | 67457-823-99 | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-823-99) / 25 mL in 1 VIAL, SINGLE-DOSE (67457-823-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 10, 2018 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 750MG BASE/VIAL | ||||
Approval Date: | Jul 10, 2018 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 1.25GM BASE/VIAL | ||||
Approval Date: | Jul 10, 2018 | TE: | AP | RLD: | Yes |
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