Details for New Drug Application (NDA): 091532
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NDA 091532 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 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 suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 091532
| Tradename: | VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER |
| Applicant: | Samson Medcl |
| Ingredient: | vancomycin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091532
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER | vancomycin hydrochloride | POWDER;INTRAVENOUS | 091532 | ANDA | SAMSON MEDICAL TECHNOLOGIES LLC | 66288-7100 | 66288-7100-1 | 1 BAG in 1 BAG (66288-7100-1) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 100GM BASE | ||||
| Approval Date: | Jan 6, 2016 | TE: | RLD: | No | |||||
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