Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020550
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALTREX | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | Tablet; Oral | Prescription | None | No | No |
| VALTREX | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET; ORAL | Prescription | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/29/2003 | SUPPL-19 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020550s019lbl.pdf | |
| 04/01/2003 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020550s005lbl.pdf | |
| 06/25/2001 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s10s13lbl.pdf | |
| 06/25/2001 | SUPPL-12 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s12lbl.pdf | |
| 06/25/2001 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s10s13lbl.pdf |