Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021039
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AGENERASE | AMPRENAVIR | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 11/04/2005 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021039s017lbl.pdf | |
| 02/12/2004 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21007slr016,21039slr016_agenerase_lbl.pdf | |
| 10/02/2002 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf | |
| 10/02/2002 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf | |
| 08/02/2002 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s11,21039s10lbl.pdf | |
| 05/11/2001 | SUPPL-6 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007SE7006_Agenerase_Prntlbl.pdf | |
| 04/15/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-007_Agenerase_prntlbl.pdf |