Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019869
Company: ICU MEDICAL INC
Company: ICU MEDICAL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | STERILE WATER FOR INJECTION | 100% | LIQUID;N/A | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/26/1989 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/20/2003 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
03/20/2002 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
06/26/2001 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
11/04/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
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08/14/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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08/27/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/28/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/10/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/31/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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 |