Drugs@FDA: FDA-Approved Drugs
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 |