Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206369
Company: HIKMA
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 |