Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017656
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 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
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 No AT 017656 ICU MEDICAL INC

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