Details for New Drug Application (NDA): 204107
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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 204107
Tradename: | VANCOMYCIN HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | vancomycin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 204107
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 204107 | ANDA | Fresenius Kabi, LLC | 63323-221 | 63323-221-38 | 25 VIAL in 1 TRAY (63323-221-38) / 10 mL in 1 VIAL (63323-221-33) |
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 204107 | ANDA | Fresenius Kabi, LLC | 63323-221 | 63323-221-48 | 25 VIAL in 1 TRAY (63323-221-48) / 10 mL in 1 VIAL (63323-221-43) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
Approval Date: | Dec 28, 2015 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
Approval Date: | Dec 28, 2015 | TE: | AP | RLD: | No |
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