U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206369
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) LIQUID;N/A Prescription AP No No
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (20ML) LIQUID;N/A Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/02/2015 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206369Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206369Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
09/02/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206369Orig1s000lbl.pdf

STERILE WATER FOR INJECTION

LIQUID;N/A; 100% (10ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) LIQUID;N/A Prescription No AP 217341 AM REGENT
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) LIQUID;N/A Prescription No AP 206369 HIKMA
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) LIQUID;N/A Prescription Yes AP 018801 HOSPIRA
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) LIQUID;N/A Prescription No AP 211188 MEDEFIL INC
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) LIQUID;N/A Prescription No AP 217536 NEXUS
Back to Top