Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 016784
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYCINE 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
02/06/1978 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
09/12/2014 SUPPL-35 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016784s035lbl.pdf
05/08/2013 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

07/08/2002 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/2002 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/2000 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1998 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1997 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/1995 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/1990 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/19/1988 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1985 SUPPL-20 Labeling

Label is not available on this site.

03/05/1987 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1985 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/1985 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/24/1985 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1983 SUPPL-15 Labeling

Label is not available on this site.

09/24/1981 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/28/1981 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1981 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/27/1981 SUPPL-11 Labeling

Label is not available on this site.

10/27/1981 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1980 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1980 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1979 SUPPL-7 Labeling

Label is not available on this site.

09/24/1979 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/1979 SUPPL-5 Labeling

Label is not available on this site.

04/26/1979 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/19/1979 SUPPL-3 Labeling

Label is not available on this site.

08/28/1978 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/1978 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/12/2014 SUPPL-35 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016784s035lbl.pdf

GLYCINE 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 Yes 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

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