Details for New Drug Application (NDA): 204125
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NDA 204125 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, Medimetriks Pharms, Meitheal, Mylan Labs Ltd, 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 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 suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 204125
| Tradename: | VANCOMYCIN HYDROCHLORIDE |
| Applicant: | Xellia Pharms Aps |
| Ingredient: | vancomycin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204125
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 204125 | ANDA | Fresenius Kabi, LLC | 63323-314 | 63323-314-66 | 1 BOTTLE in 1 CARTON (63323-314-66) / 100 mL in 1 BOTTLE |
| VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | INJECTABLE;INJECTION | 204125 | ANDA | Fresenius Kabi, LLC | 63323-314 | 63323-314-61 | 1 BOTTLE in 1 CARTON (63323-314-61) / 100 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5GM BASE/VIAL | ||||
| Approval Date: | Dec 28, 2015 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL | ||||
| Approval Date: | Dec 28, 2015 | TE: | AP | RLD: | No | ||||
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