Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020126
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZONALON DOXEPIN HYDROCHLORIDE 5% CREAM;TOPICAL Prescription None 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
04/01/1994 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
12/20/2002 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20126slr006_Zonalon_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20126slr006ltr.pdf
08/01/1996 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1995 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1994 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/1995 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2002 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20126slr006_Zonalon_lbl.pdf

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