Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 202317
Company: HELSINN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VALCHLOR MECHLORETHAMINE HYDROCHLORIDE EQ 0.016% BASE GEL;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
08/23/2013 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202317lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202317Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202317Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202317Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/08/2016 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/29/2015 SUPPL-4 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202317s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202317Orig1s004ltr.pdf
10/13/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/08/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/09/2014 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/29/2015 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202317s004lbl.pdf
08/23/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202317lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English