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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020934
Company: MYLAN

Products on NDA 020934

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020934

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.

Labels for NDA 020934

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

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