Drugs@FDA: FDA-Approved Drugs
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TROPHAMINE | AMINO ACIDS | 6% (6GM/100ML) | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
TROPHAMINE 10% | AMINO ACIDS | 10% (10GM/100ML) | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/20/1984 | 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 |
---|---|---|---|---|---|
10/26/2020 | SUPPL-36 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019018Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019018Orig1s036ltr.pdf | |
01/17/2014 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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11/08/2013 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/19/2013 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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03/24/2004 | SUPPL-18 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19018scs018_trophamine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19018scs018ltr.pdf | |
06/20/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/11/2000 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/14/1996 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/28/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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09/28/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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12/11/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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04/11/1990 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/23/1998 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/19/1988 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/07/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
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09/07/1988 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
01/13/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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07/09/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
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10/09/1986 | SUPPL-2 | Labeling |
Label is not available on this site. |
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02/21/1985 | 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 |
---|---|---|---|---|---|
10/26/2020 | SUPPL-36 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019018Orig1s036lbl.pdf | |
03/24/2004 | SUPPL-18 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19018scs018_trophamine_lbl.pdf |