Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THAM | TROMETHAMINE | 18GM/500ML (3.6GM/100ML) | SOLUTION;INJECTION | Prescription | AP | Yes | Yes |
| THAM-E | POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE | 370MG/VIAL;1.75GM/VIAL;36GM/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 12/16/1965 | ORIG-1 | Approval | Type 1 - New Molecular Entity and 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-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/2013 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/2006 | SUPPL-40 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013025s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/013025s040ltr.pdf | |
| 02/11/2000 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 02/12/1998 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/2000 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 03/29/1996 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1989 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/1986 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/1984 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1984 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/05/1983 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/1982 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/17/1981 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/09/1984 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/27/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 09/27/1982 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/14/1980 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/06/1980 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/1980 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/1980 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/27/1977 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/08/1976 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1976 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/14/1975 | SUPPL-10 | 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 |
|---|---|---|---|---|---|
| 07/20/2006 | SUPPL-40 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013025s040lbl.pdf | |
| 07/20/2006 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013025s040lbl.pdf |
THAM
SOLUTION;INJECTION; 18GM/500ML (3.6GM/100ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| THAM | TROMETHAMINE | 18GM/500ML (3.6GM/100ML) | SOLUTION;INJECTION | Prescription | Yes | AP | 013025 | HOSPIRA |
| TROMETHAMINE | TROMETHAMINE | 18GM/500ML (3.6GM/100ML) | SOLUTION;INJECTION | Prescription | No | AP | 211558 | B BRAUN MEDICAL |
| TROMETHAMINE | TROMETHAMINE | 18GM/500ML (3.6GM/100ML) | SOLUTION;INJECTION | Prescription | No | AP | 213116 | MILLA PHARMS |
THAM-E
There are no Therapeutic Equivalents.