Details for New Drug Application (NDA): 209689
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NDA 209689 describes STERILE WATER FOR INJECTION, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Hikma, Hospira, Medefil Inc, Nephron, Nexus, B Braun, Baxter Hlthcare, Icu Medical Inc, and Taro, and is included in fifteen NDAs. It is available from fifteen suppliers. Additional details are available on the STERILE WATER FOR INJECTION profile page.
The generic ingredient in STERILE WATER FOR INJECTION is sterile water for injection. There are one thousand and seventy-two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.
The generic ingredient in STERILE WATER FOR INJECTION is sterile water for injection. There are one thousand and seventy-two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.
Summary for 209689
| Tradename: | STERILE WATER FOR INJECTION |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | sterile water for injection |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209689
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| STERILE WATER FOR INJECTION | sterile water for injection | LIQUID;N/A | 209689 | ANDA | Becton Dickinson and Company | 17271-750 | 17271-750-07 | 10 BAG in 1 CASE (17271-750-07) / 1000 mL in 1 BAG |
| STERILE WATER FOR INJECTION | sterile water for injection | LIQUID;N/A | 209689 | ANDA | Fresenius Kabi USA, LLC | 63323-178 | 63323-178-76 | 10 BAG in 1 CASE (63323-178-76) / 1000 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;N/A | Strength | 100% | ||||
| Approval Date: | Nov 24, 2017 | TE: | AP | RLD: | No | ||||
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