You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 5, 2024

Details for New Drug Application (NDA): 206369


✉ Email this page to a colleague

« Back to Dashboard


NDA 206369 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.
Summary for 206369
Tradename:STERILE WATER FOR INJECTION
Applicant:Hikma
Ingredient:sterile water for injection
Patents:0
Suppliers and Packaging for NDA: 206369
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 206369 ANDA Hikma Pharmaceuticals USA Inc. 0641-6147 0641-6147-10 10 VIAL in 1 CARTON (0641-6147-10) / 10 mL in 1 VIAL (0641-6147-01)
STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 206369 ANDA Hikma Pharmaceuticals USA Inc. 0641-6147 0641-6147-25 25 VIAL in 1 CARTON (0641-6147-25) / 10 mL in 1 VIAL (0641-6147-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LIQUID;N/AStrength100% (10ML)
Approval Date:Sep 2, 2015TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:LIQUID;N/AStrength100% (20ML)
Approval Date:Sep 2, 2015TE:RLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.