Details for New Drug Application (NDA): 203300
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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 203300
Tradename: | VANCOMYCIN HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | vancomycin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 203300
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 203300 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9356 | 0143-9356-25 | 25 VIAL in 1 CARTON (0143-9356-25) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9356-01) |
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 203300 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9357 | 0143-9357-10 | 10 VIAL in 1 CARTON (0143-9357-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9357-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
Approval Date: | Aug 11, 2020 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
Approval Date: | Aug 11, 2020 | TE: | AP | RLD: | No |
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