Details for New Drug Application (NDA): 018801
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NDA 018801 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 018801
| Tradename: | STERILE WATER FOR INJECTION |
| Applicant: | Hospira |
| Ingredient: | sterile water for injection |
| Patents: | 0 |
Suppliers and Packaging for NDA: 018801
| 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 | 018801 | NDA | Henry Schein, Inc. | 0404-9959 | 0404-9959-10 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9959-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
| STERILE WATER FOR INJECTION | sterile water for injection | LIQUID;N/A | 018801 | NDA | Henry Schein, Inc. | 0404-9959 | 0404-9959-20 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9959-20) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | LIQUID;N/A | Strength | 100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 27, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;N/A | Strength | 100% (10ML) | ||||
| Approval Date: | Oct 27, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;N/A | Strength | 100% (20ML) | ||||
| Approval Date: | Oct 27, 1982 | TE: | AP | RLD: | Yes | ||||
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