Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018523
Company: BAXTER HLTHCARE
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
02/19/1982 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
09/26/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/28/2011 SUPPL-20 Labeling-Container/Carton Labels

Label is not available on this site.

05/26/1999 SUPPL-15 Labeling

Label is not available on this site.

09/14/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/14/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/18/1990 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/26/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/30/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/26/1985 SUPPL-6 Labeling

Label is not available on this site.

02/28/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/24/1985 SUPPL-2 Manufacturing (CMC)

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English