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COVID-19 INFORMATION

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Get the latest public health information from CDC
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Learn more about COVID-19 and you from HHS

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U.S. National Library of Medicine
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DailyMed


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The DailyMed database contains 141239 labeling submitted to the Food and Drug
Administration (FDA) by companies. DailyMed does not contain a complete listing
of labeling for FDA-regulated products (e.g., labeling that is not submitted to
the FDA). See ABOUT DAILYMED for more information.


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NEWS

News


DAILYMED ANNOUNCEMENTS

Posted: September 13, 2021

Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in
individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA
package insert that included the approved new COVID-19 vaccine tradename
COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of
labels with the new tradename.

At present, Pfizer does not plan to produce any product with these new NDCs and
labels over the next few months while EUA authorized product is still available
and being made available for U.S. distribution. As such, the CDC, AMA, and drug
compendia may not publish these new codes until Pfizer has determined when the
product will be produced with the BLA labels.

 * More Info


GET RSS NEWS & UPDATES

The DailyMed RSS feed provides updates and information about new drug labels
approved by the FDA and published on NLM's DailyMed Web site.


ABOUT DAILYMED

About DailyMed

The National Library of Medicine (NLM)’s DailyMed searchable database provides
the most recent labeling submitted to the Food and Drug Administration (FDA) by
companies and currently in use (i.e., "in use" labeling). DailyMed contains
labeling for prescription and nonprescription drugs for human and animal use,
and for additional products such as medical gases, devices, cosmetics, dietary
supplements, and medical foods. The NLM provides DailyMed to the public and does
not accept advertisements. The labeling on DailyMed is typically reformatted to
make them easier to read.

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FDA RESOURCES

FDA Resources


SPL, OTHER PRESCRIPTION DRUG LABELING RESOURCES, AND GUIDANCES

 * FDA's Structured Product Labeling Resources
 * FDA's Prescription Drug Labeling Resources
 * FDA's Drug Guidances


NLM SPL RESOURCES

NLM SPL Resources


THE FOLLOWING STRUCTURED PRODUCT LABELING (SPL) RESOURCES HAVE BEEN CREATED TO
ASSIST INDUSTRY PROFESSIONALS.


DOWNLOAD DATA

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SPL IMAGE GUIDELINES

Guidelines for SPL image files of oral solid dosage forms that are submitted to
the FDA with SPL documents.


PRESENTATIONS & ARTICLES

Stay informed through recent SPL related articles, online workshops,
presentations and more.


APPLICATION DEVELOPMENT SUPPORT

Application Development Support


RESOURCES TO GET THE MOST OUT OF DAILYMED

 * Web Services
 * Mapping Files


HELP

Help


TIPS ON HOW TO USE THE SITE

Need help using DailyMed? Learn how to find information you need, how to use a
NDC Code, and more.

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