Details for New Drug Application (NDA): 205779
✉ Email this page to a colleague
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 205779
Tradename: | VANCOMYCIN HYDROCHLORIDE |
Applicant: | Eugia Pharma |
Ingredient: | vancomycin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 205779
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 205779 | ANDA | NorthStar Rx LLC | 16714-517 | 16714-517-01 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (16714-517-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE |
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 205779 | ANDA | NorthStar Rx LLC | 16714-699 | 16714-699-01 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (16714-699-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5GM BASE/VIAL | ||||
Approval Date: | Mar 29, 2016 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL | ||||
Approval Date: | Mar 29, 2016 | TE: | AP | RLD: | No |
Complete Access Available with Subscription