Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020409
Company: TEVA BRANDED PHARM
Company: TEVA BRANDED PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NASAREL | FLUNISOLIDE | 0.029MG/SPRAY | SPRAY, METERED;NASAL | 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 |
---|---|---|---|---|---|---|---|
03/08/1995 | 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 |
---|---|---|---|---|---|
03/17/2008 | SUPPL-22 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020409s022ltr.pdf |
08/23/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/09/2002 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18148S030ltr.pdf |
06/29/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/15/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/27/2001 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20409S6LTR.PDF |
05/09/2002 | SUPPL-5 | 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-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/21/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/01/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |