Requesting a Pre-Assigned Application number

  1. Before you request a pre-assigned  application number, apply for a secure email with the FDA by contacting secureemail@fda.hhs.gov. If using a US Agent to request the number, please be sure that the agent has established a secure e-mail.
  2. Send one email per application number request to cderappnumrequest@fda.hhs.gov. Please note that at this time the Electronic Submission Gateway (ESG) cannot accept requests for pre-assigned numbers.

    Include the following information in your e-mail:

    • Subject: Request for a Pre-Assigned <insert Application Type> Number
    • Text:
      • Name of Applicant that will be on form (FDA 1571 or 356h) or transmittal letter (Master File)
      • Applicant Address (street, city, state, zip code)
      • Name of US Contact, Phone Number, Fax Number, Email Address
      • Name of drug or Subject of Master File  <insert Established Drug Name (if applicable); or sponsor code name with short description of  product,  Dosage Form, Strengths if applicable >
      • Drug Trade Name (if applicable)

    If requesting an NDA or ANDA, please include the following:

    • Indicate whether or not the application for which a pre-assigned number is being requested is an “old antibiotic”. An “old antibiotic” is an application for a drug that contains an antibiotic that was the subject of any marketing application received by the Secretary on or before November 20, 1997. See Guidance for additional information.

    If requesting for an IND, NDA, or BLA please include the following:

    • Indication
    • Review Division, if known

    If requesting for an IND, please include one of the following:

    • Commercial IND if the product under investigation is intended to be commercialized at a later date
    • Research IND if the product under investigation is not intended to be commercialized at a later date. Research INDs are generally sponsored by individual investigators, academic institutions and non-profit entities. May include INDs for emergency use and expanded access.

    If requesting for a Master File please include the following:

    • Manufacturing Site Name
    • Manufacturing Site Address
    • Master File Type (e.g. Type II, Type III, Type IV, or Type V). For information on Master File Types see the Drug Master Files (DMFs) webpage.

    If requesting for an ANDA, please include the following:

    • Reference Listed Drug Name and RLD Number
    • Is there a NCE exclusivity? YES or NO
      • If yes, when does it expire?
    • Have you filed any applications for this active ingredient before? If YES, answer question below
      • Please specify the ANDA Number, Drug, Dosage Form, Strength
  3. A pre-assigned number will be issued within 3 business days.

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Sample e-mail

Pre Assigned Number Sample Email 

The fastest and most direct route to your reviewers is through the Electronic Submission Gateway. Please consider using it for all your IND, NDA, ANDA, or BLA regulatory submissions. See Electronic Submissions Gateway for more information.

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Page Last Updated: 02/26/2018
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