Drugs@FDA: FDA-Approved Drugs
Company: MAYER LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TODAY | NONOXYNOL-9 | 1GM | SPONGE;VAGINAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/01/1983 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2014 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/2010 | SUPPL-34 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018683s034ltr.pdf |
| 04/22/2005 | SUPPL-30 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018683s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018683s030ltr.pdf | ||
| 11/03/2004 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18683s028ltr.pdf |
| 05/29/1992 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1992 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1990 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 11/21/1990 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/13/1989 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/17/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/25/1987 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1986 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/10/1985 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/1984 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/30/1984 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/27/1984 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/30/1984 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/01/1983 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/13/1984 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/22/1983 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/20/1984 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/22/1983 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/22/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1984 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/22/2005 | SUPPL-30 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018683s030lbl.pdf |