Details for New Drug Application (NDA): 065397
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NDA 065397 describes VANCOMYCIN HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Lupin, Orient Pharma Co Ltd, Pai Holdings, Strides Pharma, Watson Labs, Alkem Labs Ltd, Amneal, Aspiro, Avet Lifesciences, Eugia Pharma, Eurofarma, Gland, Hikma, Hikma Pharms, Hospira, Hospira Inc, Knack, Meitheal, Mylan Labs Ltd, Plano Pharms, Sagent Pharms, Slate Run Pharma, Teva Pharms Usa, Xellia Pharms Aps, Samson Medcl, Steriscience, Zhejiang Novus Pharm, and Baxter Hlthcare, and is included in fifty-four NDAs. It is available from thirty suppliers. Additional details are available on the VANCOMYCIN HYDROCHLORIDE profile page.
The generic ingredient in VANCOMYCIN HYDROCHLORIDE is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
The generic ingredient in VANCOMYCIN HYDROCHLORIDE is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 065397
| Tradename: | VANCOMYCIN HYDROCHLORIDE |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | vancomycin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065397
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 065397 | ANDA | Mylan Institutional LLC | 67457-339 | 67457-339-50 | 10 VIAL in 1 CARTON (67457-339-50) / 10 mL in 1 VIAL (67457-339-00) |
| VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 065397 | ANDA | Mylan Institutional LLC | 67457-340 | 67457-340-01 | 10 VIAL in 1 CARTON (67457-340-01) / 20 mL in 1 VIAL (67457-340-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Dec 30, 2008 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Dec 30, 2008 | TE: | AP | RLD: | No | ||||
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