Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077393
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STERILE WATER | STERILE WATER | 10ML | INJECTABLE; INJECTION | Prescription | None | No | No |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 08/11/2006 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077393Orig1s000.pdf |
STERILE WATER
There are no Therapeutic Equivalents.
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
LIQUID;N/A; 100%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | Yes | AP | 018802 | HOSPIRA |
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | No | AP | 209689 | FRESENIUS KABI USA |
| STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | No | AP | 212735 | HIKMA |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | Yes | AP | 019633 | B BRAUN |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | Yes | AP | 018632 | BAXTER HLTHCARE |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | No | AP | 088400 | FRESENIUS KABI USA |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | Yes | AP | 018233 | ICU MEDICAL INC |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | Yes | AP | 019869 | ICU MEDICAL INC |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | No | AP | 077393 | TARO |