Details for New Drug Application (NDA): 210274
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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 210274
Tradename: | VANCOMYCIN HYDROCHLORIDE |
Applicant: | Zhejiang Novus Pharm |
Ingredient: | vancomycin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 210274
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | POWDER;INTRAVENOUS, ORAL | 210274 | NDA | HIKMA PHARMACEUTICALS USA INC. | 0143-9161 | 0143-9161-25 | 25 VIAL in 1 PACKAGE (0143-9161-25) / 513 mg in 1 VIAL (0143-9161-01) |
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | POWDER;INTRAVENOUS, ORAL | 210274 | NDA | HIKMA PHARMACEUTICALS USA INC. | 0143-9162 | 0143-9162-10 | 10 VIAL in 1 PACKAGE (0143-9162-10) / 1025 mg in 1 VIAL (0143-9162-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS, ORAL | Strength | EQ 500MG BASE/VIAL | ||||
Approval Date: | Jan 20, 2023 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS, ORAL | Strength | EQ 1GM BASE/VIAL | ||||
Approval Date: | Jan 20, 2023 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS, ORAL | Strength | EQ 5GM BASE/VIAL | ||||
Approval Date: | Jan 20, 2023 | TE: | RLD: | Yes |
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