Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020088
Company: WYETH PHARMS INC
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. |