Details for New Drug Application (NDA): 091554
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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 091554
Tradename: | VANCOMYCIN HYDROCHLORIDE |
Applicant: | Mylan Labs Ltd |
Ingredient: | vancomycin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 091554
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 091554 | ANDA | Mylan Institutional LLC | 67457-342 | 67457-342-10 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-342-10) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL | ||||
Approval Date: | Sep 19, 2011 | TE: | AP | RLD: | No |
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