Details for New Drug Application (NDA): 215338
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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-one suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 215338
Tradename: | VANCOMYCIN HYDROCHLORIDE |
Applicant: | Amneal |
Ingredient: | vancomycin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 215338
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | FOR SOLUTION;ORAL | 215338 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2261 | 69238-2261-3 | 80 mL in 1 BOTTLE (69238-2261-3) |
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | FOR SOLUTION;ORAL | 215338 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2261 | 69238-2261-5 | 300 mL in 1 BOTTLE (69238-2261-5) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 250MG BASE/5ML | ||||
Approval Date: | Jun 23, 2023 | TE: | AA | RLD: | No |
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