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Last Updated: March 18, 2024

Sterile water for injection - Generic Drug Details


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What are the generic sources for sterile water for injection and what is the scope of freedom to operate?

Sterile water for injection is the generic ingredient in three branded drugs marketed by Abraxis Pharm, Hospira, Am Regent, Fresenius Kabi Usa, Hikma, Medefil Inc, Nephron, Nexus, B Braun, Baxter Hlthcare, Icu Medical Inc, and Taro, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for sterile water for injection. Twenty-one suppliers are listed for this compound.

Summary for sterile water for injection
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US Patents and Regulatory Information for sterile water for injection

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medefil Inc STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 211188-002 Dec 2, 2019 RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nexus STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 217536-001 Jul 11, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 018801-002 Oct 27, 1982 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 018801-004 Oct 27, 1982 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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