Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020088
Company: WYETH PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORPLANT SYSTEM IN PLASTIC CONTAINER LEVONORGESTREL 36MG/IMPLANT IMPLANT;IMPLANTATION Discontinued None No 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
12/10/1990 ORIG-1 Approval 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
01/06/2004 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20088slr018ltr.pdf
07/18/2005 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020088s017ltr.pdf
01/15/2002 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20088s16ltr.pdf
03/14/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/21/1999 SUPPL-12 Labeling

Label is not available on this site.

03/30/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/08/1997 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1997 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1996 SUPPL-6 Labeling

Label is not available on this site.

07/07/1995 SUPPL-5 Labeling

Label is not available on this site.

08/30/1995 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/11/1994 SUPPL-3 Labeling

Label is not available on this site.

03/26/1993 SUPPL-1 Labeling

Label is not available on this site.

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