Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020934
Company: NORVIUM BIOSCIENCE
Company: NORVIUM BIOSCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LUXIQ | BETAMETHASONE VALERATE | 0.12% | AEROSOL, FOAM;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
02/28/1999 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20934lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20934ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20934.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/11/2006 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020934s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020934s016LTR.pdf | |
06/16/2006 | SUPPL-15 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/29/2003 | SUPPL-12 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20934scs012_luxiq_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20934scs012ltr.pdf | |
10/31/2003 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20934slr011ltr.pdf |
11/03/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/08/2002 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20934scp007ltr.pdf |
10/09/2002 | SUPPL-6 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20934scm006ltr.pdf |
05/06/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/28/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20934s4ltr.pdf |
11/12/2000 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/11/2006 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020934s016lbl.pdf | |
12/29/2003 | SUPPL-12 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20934scs012_luxiq_lbl.pdf |
02/28/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20934lbl.pdf |