Drugs@FDA: FDA-Approved Drugs
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NEPHRAMINE 5.4% | AMINO ACIDS | 5.4% (5.4GM/100ML) | INJECTABLE;INJECTION | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
02/24/1978 | 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 |
---|---|---|---|---|---|
08/27/2014 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/19/2013 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/04/2006 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017766s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017766s030LTR.pdf | |
05/05/2004 | SUPPL-29 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17766scs029_nephramine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17766scs029ltr.pdf | |
06/12/2002 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17766s028ltr.pdf |
06/14/1996 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/28/1994 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/08/1993 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/28/1992 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/11/1991 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/18/1991 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/11/1990 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/13/1988 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
07/09/1987 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
10/09/1986 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
09/10/1985 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
04/23/1985 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
06/14/1985 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/11/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
04/11/1988 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/18/1982 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/08/1982 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
06/17/1982 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/04/1981 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/10/1980 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/31/1979 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
08/31/1979 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/05/1979 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/04/1979 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/11/1978 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/04/2006 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017766s030lbl.pdf | |
05/05/2004 | SUPPL-29 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17766scs029_nephramine_lbl.pdf |