Details for New Drug Application (NDA): 217489
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NDA 217489 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, Hikma, Hikma Pharms, Hospira, Hospira Inc, Knack, Medimetriks Pharms, Meitheal, Mylan Labs Ltd, Sagent Pharms, Sandoz, Sandoz Inc, Slate Run Pharma, 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 217489
| Tradename: | VANCOMYCIN HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | vancomycin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217489
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | POWDER;INTRAVENOUS | 217489 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9152 | 0143-9152-10 | 10 VIAL in 1 CARTON (0143-9152-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | POWDER;INTRAVENOUS | 217489 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9153 | 0143-9153-10 | 10 VIAL in 1 CARTON (0143-9153-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 1.25GM BASE/VIAL | ||||
| Approval Date: | Jun 29, 2023 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Feb 12, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 1.5GM BASE/VIAL | ||||
| Approval Date: | Jun 29, 2023 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Feb 12, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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