Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018683
Company: MAYER LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TODAY NONOXYNOL-9 1GM SPONGE;VAGINAL Over-the-counter None Yes Yes
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

TODAY

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPONGE;VAGINAL; 1GM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
TODAY NONOXYNOL-9 1GM SPONGE;VAGINAL Over-the-counter Yes 018683 MAYER LABS INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English