Drugs@FDA: FDA-Approved Drugs
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HEPATAMINE 8% | AMINO ACIDS | 8% (8GM/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 |
---|---|---|---|---|---|---|---|
08/03/1982 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
11/17/2014 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/19/2013 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/29/2004 | SUPPL-22 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18676scs022_hepatamine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18676scs022ltr.pdf | |
06/20/2000 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/11/2000 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/14/1996 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/28/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/08/1993 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/28/1992 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/11/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/11/1990 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/13/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
07/09/1987 | SUPPL-10 | Labeling |
Label is not available on this site. |
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11/13/1986 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/03/1986 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
07/16/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
04/10/1985 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/03/1986 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
04/11/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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03/11/1988 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/13/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
10/15/1982 | 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 |
---|---|---|---|---|---|
04/29/2004 | SUPPL-22 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18676scs022_hepatamine_lbl.pdf |