FDA approval · Drugs@FDA
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINERvancomycin hydrochloride
NDA050671 ·
FDA approved the original new drug application for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER on April 29, 1993, sponsored by BAXTER HLTHCARE. FDA has approved 1 efficacy supplement on the application since, the most recent on January 8, 1998.
- Application
- NDA050671
- Sponsor
- BAXTER HLTHCARE
- Original approval
- Review
- standard review
- Submission class
- Type 3 - New Dosage Form
- Active ingredient
- vancomycin hydrochloride
Browse every approval whose brand starts with V, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| vancomycin hydrochloride EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) | SOLUTION | INTRAVENOUS | Prescription |
| vancomycin hydrochloride EQ 1GM BASE/200ML (EQ 5MG BASE/ML) | SOLUTION | INTRAVENOUS | Prescription |
| vancomycin hydrochloride EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | SOLUTION | INTRAVENOUS | Prescription |
| vancomycin hydrochloride EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) | SOLUTION | INTRAVENOUS | Prescription |
| vancomycin hydrochloride EQ 750MG BASE/150ML (EQ 5MG BASE/ML) | SOLUTION | INTRAVENOUS | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-2 | standard |
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 12 · Manufacturing (CMC) 5. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to BAXTER HLTHCARE
- December 24, 2008NEXTERONENDA022325
- August 5, 2008CEFEPIME IN PLASTIC CONTAINERNDA050817
- March 21, 2002MESNEXNDA020855
- August 26, 1998PROSOL 20% SULFITE FREE IN PLASTIC CONTAINERNDA020849
- September 29, 1997CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINERNDA020734
- March 26, 1997CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINERNDA020678
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