Details for New Drug Application (NDA): 050671
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NDA 050671 describes VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER, which is a drug marketed by Samson Medcl and Baxter Hlthcare and is included in two NDAs. It is available from two suppliers. Additional details are available on the VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER profile page.
The generic ingredient in VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER 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.
The generic ingredient in VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER 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 050671
| Tradename: | VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER |
| Applicant: | Baxter Hlthcare |
| Ingredient: | vancomycin hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 050671
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER | vancomycin hydrochloride | SOLUTION;INTRAVENOUS | 050671 | NDA | Baxter Healthcare Corporation | 0338-0122 | 0338-0122-04 | 250 mL in 1 BAG (0338-0122-04) |
| VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER | vancomycin hydrochloride | SOLUTION;INTRAVENOUS | 050671 | NDA | Baxter Healthcare Corporation | 0338-0124 | 0338-0124-04 | 300 mL in 1 BAG (0338-0124-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | ||||
| Approval Date: | Apr 29, 1993 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 750MG BASE/150ML (EQ 5MG BASE/ML) | ||||
| Approval Date: | Dec 20, 2010 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 1GM BASE/200ML (EQ 5MG BASE/ML) | ||||
| Approval Date: | Mar 1, 1999 | TE: | RLD: | Yes | |||||
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