Details for New Drug Application (NDA): 201048
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NDA 201048 describes VANCOMYCIN HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Pai Holdings, Strides Pharma, Watson Labs, Alkem Labs Ltd, Amneal, Aspiro, Avet Lifesciences, Eugia Pharma, Gland, Hikma, Hikma Pharms, Hospira, Hospira Inc, Knack, Medimetriks Pharms, 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 twenty-eight 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-four 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-four suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 201048
| Tradename: | VANCOMYCIN HYDROCHLORIDE |
| Applicant: | Plano Pharms |
| Ingredient: | vancomycin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 201048
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 201048 | ANDA | Plano Pharmaceuticals Inc. | 87188-203 | 87188-203-01 | 1 VIAL in 1 CARTON (87188-203-01) / 100 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5GM BASE/VIAL | ||||
| Approval Date: | Aug 10, 2012 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL | ||||
| Approval Date: | Aug 10, 2012 | TE: | RLD: | No | |||||
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