Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020793
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAFCIT | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
| CAFCIT | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/02/2020 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020793s019lbl.pdf | |
| 06/11/2010 | SUPPL-9 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020793s009lbl.pdf | |
| 04/12/2000 | SUPPL-1 | Efficacy-New Route Of Administration | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20793s1lbl.pdf | |
| 09/21/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20793lbl.pdf |