Drugs@FDA: FDA-Approved Drugs
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETIC ACID 0.25% IN PLASTIC CONTAINER | ACETIC ACID, GLACIAL | 250MG/100ML | SOLUTION;IRRIGATION, URETHRAL | Prescription | AT | 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 |
|---|---|---|---|---|---|---|---|
| 06/02/1976 | 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 |
|---|---|---|---|---|---|
| 06/12/2014 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/2000 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 02/04/1998 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/19/1997 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/30/1992 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/24/1993 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/25/1988 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/1986 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/25/1984 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/1984 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1982 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/06/1981 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/24/1982 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/01/1980 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/08/1980 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/11/1980 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/1980 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/1980 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1981 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/20/1980 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/04/1979 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1979 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/18/1979 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/26/1979 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/01/1979 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/22/1978 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/22/1978 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1978 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/09/1977 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1977 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1976 | SUPPL-1 | Labeling |
Label is not available on this site. |
ACETIC ACID 0.25% IN PLASTIC CONTAINER
SOLUTION;IRRIGATION, URETHRAL; 250MG/100ML
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETIC ACID 0.25% IN PLASTIC CONTAINER | ACETIC ACID, GLACIAL | 250MG/100ML | SOLUTION;IRRIGATION, URETHRAL | Prescription | No | AT | 018161 | B BRAUN |
| ACETIC ACID 0.25% IN PLASTIC CONTAINER | ACETIC ACID, GLACIAL | 250MG/100ML | SOLUTION;IRRIGATION, URETHRAL | Prescription | No | AT | 018523 | BAXTER HLTHCARE |
| ACETIC ACID 0.25% IN PLASTIC CONTAINER | ACETIC ACID, GLACIAL | 250MG/100ML | SOLUTION;IRRIGATION, URETHRAL | Prescription | Yes | AT | 017656 | ICU MEDICAL INC |