Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020444
Company: GLAXOSMITHKLINE LLC
Company: GLAXOSMITHKLINE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLOLAN | EPOPROSTENOL SODIUM | EQ 0.5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP1 | Yes | Yes |
| FLOLAN | EPOPROSTENOL SODIUM | EQ 1.5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP1 | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/24/2021 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020444s025lbl.pdf | |
| 08/24/2021 | SUPPL-25 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020444s025lbl.pdf | |
| 12/12/2018 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s024lbl.pdf | |
| 10/23/2018 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s023lbl.pdf | |
| 05/14/2018 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s022lbl.pdf | |
| 04/17/2015 | SUPPL-21 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020444s021lbl.pdf |
| 03/29/2011 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020444s018lbl.pdf | |
| 03/12/2008 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020444s016lbl.pdf | |
| 04/14/2000 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20444S03LBL.PDF |