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Details for New Drug Application (NDA): 018233
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NDA 018233 describes STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Hospira, Icu Medical Inc, and Taro, and is included in eight NDAs. It is available from twelve suppliers. Additional details are available on the STERILE WATER FOR INJECTION IN PLASTIC CONTAINER profile page.
The generic ingredient in STERILE WATER FOR INJECTION IN PLASTIC CONTAINER is sterile water for injection. There are one thousand and seventy-two drug master file entries for this compound. Fourteen 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 IN PLASTIC CONTAINER is sterile water for injection. There are one thousand and seventy-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.
Summary for 018233
| Tradename: | STERILE WATER FOR INJECTION IN PLASTIC CONTAINER |
| Applicant: | Icu Medical Inc |
| Ingredient: | sterile water for injection |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 018233
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | sterile water for injection | LIQUID;N/A | 018233 | NDA | Hospira, Inc. | 0409-7990 | 0409-7990-09 | 12 POUCH in 1 CASE (0409-7990-09) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | sterile water for injection | LIQUID;N/A | 018233 | NDA | ICU Medical Inc. | 0990-7990 | 0990-7990-09 | 12 POUCH in 1 CASE (0990-7990-09) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;N/A | Strength | 100% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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