Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017865
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER GLYCINE 1.5GM/100ML SOLUTION;IRRIGATION 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
05/30/1980 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-48 Manufacturing (CMC)

Label is not available on this site.

02/21/2006 SUPPL-45 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017865s045ltr.pdf
08/14/2001 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/2002 SUPPL-41 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17865slr041ltr.pdf
09/03/2002 SUPPL-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17865slr040ltr.pdf
11/24/1999 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

07/17/2002 SUPPL-38 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17865slr038ltr.pdf
04/29/1997 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1994 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1993 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

04/26/1991 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1991 SUPPL-31 Labeling

Label is not available on this site.

03/26/1991 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1991 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1989 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1985 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1985 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1984 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1984 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1985 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1982 SUPPL-16 Labeling

Label is not available on this site.

12/22/1982 SUPPL-14 Labeling

Label is not available on this site.

12/22/1982 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1981 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1982 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1982 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1981 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1981 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1981 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1981 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1981 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1980 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1980 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER

SOLUTION;IRRIGATION; 1.5GM/100ML
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER GLYCINE 1.5GM/100ML SOLUTION;IRRIGATION Prescription No AT 017865 BAXTER HLTHCARE
GLYCINE 1.5% IN PLASTIC CONTAINER GLYCINE 1.5GM/100ML SOLUTION;IRRIGATION Prescription No AT 016784 B BRAUN
GLYCINE 1.5% IN PLASTIC CONTAINER GLYCINE 1.5GM/100ML SOLUTION;IRRIGATION Prescription No AT 018315 ICU MEDICAL INC

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