Details for New Drug Application (NDA): 217401
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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-one suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 217401
Tradename: | VANCOMYCIN HYDROCHLORIDE |
Applicant: | Eugia Pharma |
Ingredient: | vancomycin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 217401
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | POWDER;INTRAVENOUS | 217401 | ANDA | Eugia US LLC | 55150-471 | 55150-471-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-471-10) / 25 mL in 1 VIAL, SINGLE-DOSE |
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | POWDER;INTRAVENOUS | 217401 | ANDA | Eugia US LLC | 55150-472 | 55150-472-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-472-10) / 30 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 1.25GM BASE/VIAL | ||||
Approval Date: | Aug 4, 2023 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 1.5GM BASE/VIAL | ||||
Approval Date: | Aug 4, 2023 | TE: | AP | RLD: | No |
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