Drugs@FDA: FDA-Approved Drugs
Company: IVAX RES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NASALIDE | FLUNISOLIDE | 0.025MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED;NASAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 09/24/1981 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 08/23/2002 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/09/2002 | SUPPL-35 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18148S030ltr.pdf |
| 09/13/2000 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/2000 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/2002 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18148S030ltr.pdf |
| 02/05/1999 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/21/1998 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/02/1996 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 08/05/1994 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/17/1994 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/25/1999 | SUPPL-23 | Efficacy-New Dosing Regimen |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18148s023_nasalide.pdf |
| 03/07/1989 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/08/1989 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 12/23/1987 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 09/19/1986 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/25/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1985 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/23/1985 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/19/1986 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/1984 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/21/1985 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/21/1986 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/22/1983 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/09/1983 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1983 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1983 | SUPPL-1 | Labeling |
Label is not available on this site. |