What's New


Wikispaces : SPL-work-group - all changes
  • home: by hshatz Yesterday
    No, NDC # can never be reused for a different product or package; old rule re...
  • home: by hshatz Yesterday
    Drug listing (submissions to OC) should be done only after approval. My recom...
  • home: SPL concerns by afrins Jun 22, 2017
    can you please look into the following issues: 1) What is the right practice ...
  • All Sub-Groups by hshatz Jun 22, 2017
    ...No Meeting currently scheduled - SPL Process, Drug Listing, Establishment ...
  • SPL Working Group: SPL marketing start date by afrins Jun 22, 2017
    Can you please help me fixing my knots regarding certain issues in SPL which ...
  • Drug Listing by hshatz Jun 19, 2017
    ...Standing Teleconference: Alternating Wednesdays at 1:00 pm ET, balance of ...
  • 20170614 SPL ERDL minutes.pdf by hshatz Jun 19, 2017
    Uploaded
  • 20170517 SPL ERDL minutes final - Corrected.pdf by hshatz Jun 19, 2017
    Uploaded
  • home by hshatz Jun 19, 2017
    ...Drugs @ FDA / Pragmatics Validator [if validator is down, send an e-mail t...
  • home: by nimms Jun 15, 2017
    thank you howard for the quick reply. since the ndc # will be same. once I de...
  • home: by hshatz Jun 15, 2017
    A change in imprint requires a change in product code. You can use the same s...
  • home: Tablet imprint update error by nimms Jun 15, 2017
    i have submitted an spl few years ago and recently we have changed the imprin...
  • home: by BARoden Jun 14, 2017
    Thank you! I did but haven't received a reply yet.
  • home: by hshatz Jun 14, 2017
    Follow their instructions to contact Helpdesk at cderdirect@fda.hhs.gov.
  • home: NDC Labeler Code assignment confirmation by BARoden Jun 14, 2017
    I received a new NDC Labeler Code and am trying to and trying to confirm assi...