Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 013025
Company: HOSPIRA
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 | None | Yes | Yes |
THAM-E | POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE | 370MG/VIAL;1.75GM/VIAL;36GM/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
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 |