Details for New Drug Application (NDA): 204360
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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 204360
Tradename: | VANCOMYCIN HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | vancomycin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 204360
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 204360 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9358 | 0143-9358-01 | 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (0143-9358-01) |
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 204360 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9359 | 0143-9359-01 | 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE (0143-9359-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5GM BASE/VIAL | ||||
Approval Date: | Oct 15, 2018 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL | ||||
Approval Date: | Oct 15, 2018 | TE: | AP | RLD: | No |
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