Details for New Drug Application (NDA): 205780
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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 205780
Tradename: | VANCOMYCIN HYDROCHLORIDE |
Applicant: | Eugia Pharma |
Ingredient: | vancomycin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 205780
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 205780 | ANDA | NorthStar Rx LLC | 16714-247 | 16714-247-10 | 10 VIAL in 1 CARTON (16714-247-10) / 10 mL in 1 VIAL |
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 205780 | ANDA | NorthStar Rx LLC | 16714-309 | 16714-309-10 | 10 VIAL in 1 CARTON (16714-309-10) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
Approval Date: | Mar 31, 2016 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
Approval Date: | Mar 31, 2016 | TE: | AP | RLD: | No |
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