Details for New Drug Application (NDA): 062682
✉ Email this page to a colleague
NDA 062682 describes VANCOLED, which is a drug marketed by Lederle and Hikma and is included in two NDAs. Additional details are available on the VANCOLED profile page.
The generic ingredient in VANCOLED is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
The generic ingredient in VANCOLED is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 062682
| Tradename: | VANCOLED |
| Applicant: | Hikma |
| Ingredient: | vancomycin hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 062682
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 22, 1986 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 30, 1988 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 11, 1988 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
