Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019435
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIX PERMETHRIN 1% LOTION;TOPICAL Discontinued None No 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
03/31/1986 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019435Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/02/1988 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1988 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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