Details for New Drug Application (NDA): 088400
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NDA 088400 describes STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Icu Medical Inc, and Taro, and is included in seven NDAs. It is available from five 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. 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 IN PLASTIC CONTAINER 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 088400
| Tradename: | STERILE WATER FOR INJECTION IN PLASTIC CONTAINER |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | sterile water for injection |
| Patents: | 0 |
Suppliers and Packaging for NDA: 088400
| 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 | 088400 | ANDA | Cardinal Health 107, LLC | 55154-9588 | 55154-9588-5 | 5 VIAL in 1 BAG (55154-9588-5) / 10 mL in 1 VIAL |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | sterile water for injection | LIQUID;N/A | 088400 | ANDA | Fresenius Kabi USA, LLC | 63323-185 | 63323-185-05 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-185-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;N/A | Strength | 100% | ||||
| Approval Date: | Jan 16, 1984 | TE: | AP | RLD: | No | ||||
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