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FDA Registration - Menthol and Camphor

Menthol and Camphor are widely used as active ingredient in topical analgesic. When using as OTC Drug menthol and camphor require FDA registration, drug listing and NDC Number or NDC Labeler code.

LMG can assist drug companies which manufacture OTC analgesic drugs. Our SPL preparation and submission services include.

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Services and Fees

  FDA Registration and   U.S. Agent service

       USD 649        (Annually)

  Drug Listing

       USD 399 /        Drug

  Label Review

       USD 649 /        Drug

  DMF Submission and   U.S. Agent service

       USD 649/        (Annually)