Details for New Drug Application (NDA): 017428
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NDA 017428 describes STERILE WATER, which is a drug marketed by Baxter Hlthcare, Am Regent, Fresenius Kabi Usa, Hikma, Hospira, Medefil Inc, Nephron, Nexus, B Braun, Otsuka Icu Medcl, Taro, and Miles, and is included in twenty-two NDAs. It is available from one supplier. Additional details are available on the STERILE WATER profile page.
The generic ingredient in STERILE WATER is sterile water for injection. There are two drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.
The generic ingredient in STERILE WATER is sterile water for injection. There are two drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.
Summary for 017428
| Tradename: | STERILE WATER |
| Applicant: | Baxter Hlthcare |
| Ingredient: | sterile water for irrigation |
| Patents: | 0 |
Suppliers and Packaging for NDA: 017428
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| STERILE WATER | sterile water for irrigation | LIQUID;IRRIGATION | 017428 | NDA | Baxter Healthcare Corporation | 0338-0004 | 0338-0004-02 | 24 BOTTLE, PLASTIC in 1 CARTON (0338-0004-02) / 250 mL in 1 BOTTLE, PLASTIC |
| STERILE WATER | sterile water for irrigation | LIQUID;IRRIGATION | 017428 | NDA | Baxter Healthcare Corporation | 0338-0004 | 0338-0004-03 | 18 BOTTLE, PLASTIC in 1 CARTON (0338-0004-03) / 500 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;IRRIGATION | Strength | 100% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | Yes | ||||
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