Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020934
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUXIQ BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM;TOPICAL Prescription AB Yes Yes
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

LUXIQ

AEROSOL, FOAM;TOPICAL; 0.12%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAMETHASONE VALERATE BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM;TOPICAL Prescription No AB 078337 PERRIGO UK FINCO
BETAMETHASONE VALERATE BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM;TOPICAL Prescription No AB 207144 RICONPHARMA LLC
BETAMETHASONE VALERATE BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM;TOPICAL Prescription No AB 208204 TARO PHARM
LUXIQ BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM;TOPICAL Prescription Yes AB 020934 MYLAN

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