Details for New Drug Application (NDA): 209481
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NDA 209481 describes VANCOMYCIN HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Pai Holdings Pharm, Strides Pharma, Watson Labs, Alkem Labs Ltd, Amneal, Aspiro, Avet Lifesciences, Eugia Pharma, Gland Pharma Ltd, Hainan Poly, Hainan Poly Pharm, Hikma, Hikma Pharms, Hospira, Hospira Inc, Knack, Meitheal, Mylan Labs Ltd, Pharm Assoc, Sagent Pharms, Sandoz, Sandoz Inc, Teva Pharms Usa, Xellia Pharms Aps, Zhejiang Novus Pharm, Samson Medcl, and Baxter Hlthcare, and is included in fifty-three NDAs. It is available from twenty-five suppliers. There are five patents protecting this drug. 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-one 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-one suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 209481
| Tradename: | VANCOMYCIN HYDROCHLORIDE |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | vancomycin hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 209481
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | POWDER;INTRAVENOUS | 209481 | NDA | Mylan Institutional LLC | 67457-705 | 67457-705-75 | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-705-75) / 15 mL in 1 VIAL, SINGLE-DOSE (67457-705-00) |
| VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | POWDER;INTRAVENOUS | 209481 | NDA | Mylan Institutional LLC | 67457-823 | 67457-823-99 | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-823-99) / 25 mL in 1 VIAL, SINGLE-DOSE (67457-823-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 10, 2018 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 750MG BASE/VIAL | ||||
| Approval Date: | Jul 10, 2018 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 1.25GM BASE/VIAL | ||||
| Approval Date: | Jul 10, 2018 | TE: | AP | RLD: | Yes | ||||
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