Drugs@FDA: FDA-Approved Drugs
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FREAMINE 8.5% | AMINO ACIDS | 8.5% (8.5GM/100ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| FREAMINE HBC 6.9% | AMINO ACIDS | 6.9% (6.9GM/100ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| FREAMINE II 8.5% | AMINO ACIDS | 8.5% (8.5GM/100ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| FREAMINE III 10% | AMINO ACIDS | 10% (10GM/100ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| FREAMINE III 3% W/ ELECTROLYTES | AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE | 3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| FREAMINE III 8.5% | AMINO ACIDS | 8.5% (8.5GM/100ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| FREAMINE III 8.5% W/ ELECTROLYTES | AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE | 8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/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 |
|---|---|---|---|---|---|---|---|
| 09/24/1971 | ORIG-1 | Approval | Type 4 - New Combination | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/08/2013 | SUPPL-81 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/2013 | SUPPL-77 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/2013 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/2013 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/2014 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/2004 | SUPPL-65 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16822scs065_freamine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16822scs065ltr.pdf | |
| 06/20/2000 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/04/1999 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/1996 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1995 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/28/1994 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/1993 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/1992 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1991 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/1990 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/13/1988 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 12/28/1987 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 07/09/1987 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 07/09/1987 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 10/08/1986 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 10/21/1985 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 10/21/1985 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 06/14/1985 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1988 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 07/01/1988 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1984 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 04/11/1988 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 04/11/1988 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/15/1985 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 10/15/1985 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/23/1985 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 07/23/1985 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1982 | SUPPL-35 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/26/1982 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/17/1983 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 05/17/1983 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/03/1982 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/1983 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 06/17/1982 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/04/1981 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/10/1981 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/20/1981 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 06/20/1981 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1980 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/09/1980 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/1980 | SUPPL-22 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/07/1980 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/07/1980 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/1980 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/1980 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/1980 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/1980 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/17/1980 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/18/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/02/1978 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/02/1978 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1977 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/01/1977 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1977 | SUPPL-7 | Efficacy |
Label is not available on this site. |
||
| 05/06/1977 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/23/1975 | SUPPL-5 | 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 |
|---|---|---|---|---|---|
| 05/27/2004 | SUPPL-65 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16822scs065_freamine_lbl.pdf |