Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018603
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZOVIRAX | ACYCLOVIR SODIUM | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ZOVIRAX | ACYCLOVIR SODIUM | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ZOVIRAX | ACYCLOVIR SODIUM | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/22/1982 | ORIG-1 | Approval | Type 2 - New Active Ingredient and Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/25/2019 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018603s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018603Orig1s030ltr.pdf | |
| 05/19/2004 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18603slr027_zovirax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18603slr027ltr.pdf | |
| 01/29/2002 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18603s25ltr.pdf |
| 01/29/2002 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18603s25ltr.pdf |
| 01/29/2002 | SUPPL-23 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18603s25ltr.pdf |
| 07/12/2000 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1999 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/1999 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 06/02/1998 | SUPPL-19 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/18603s19lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/18603s19ltr.pdf | |
| 10/29/1996 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/07/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/1994 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/09/1993 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/22/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/17/1992 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1989 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/22/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/09/1990 | SUPPL-9 | Efficacy-New Indication |
Label is not available on this site. |
||
| 07/09/1984 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/31/1984 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1984 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/08/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/1990 | SUPPL-3 | Efficacy-New Indication |
Label is not available on this site. |
||
| 01/05/1983 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/14/1982 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/25/2019 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018603s030lbl.pdf | |
| 05/19/2004 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18603slr027_zovirax_lbl.pdf | |
| 06/02/1998 | SUPPL-19 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/18603s19lbl.pdf |