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# ANDA Summary Tables Updated
- URL: https://www.fdaweb.com/anda-summary-tables-updated/
- Published: 2019-02-11T12:00:00.000Z
- Updated: 2026-09-15T01:02:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143347

FDA has updated [summary table forms (XXINSERT LINKXX) for ANDA submissions](http://app.info.fda.gov/e/er?utm%5Fcampaign=SBIA%3A%20FDA%20updates%20summary%20table%20forms%20for%20ANDA%20submissions%20containing%20clinical%20endpoint%20studies&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=6458&elqTrackId=797EEC6A5618737368B106D9CEA1C933&elq=3b87068d8260476e907a05b80131f74f&elqaid=6712&elqat=1) containing clinical endpoint studies. The previous version has been updated, and now includes two separate documents — one for submissions containing [comparative clinical endpoint bioequivalence studies](http://app.info.fda.gov/e/er?utm%5Fcampaign=SBIA%3A%20FDA%20updates%20summary%20table%20forms%20for%20ANDA%20submissions%20containing%20clinical%20endpoint%20studies&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=6457&elqTrackId=4D68662CB6E2FACBF4D03DF51AB8071D&elq=3b87068d8260476e907a05b80131f74f&elqaid=6712&elqat=1), and the other for submissions containing [irritation/sensitization/adhesion studies](http://app.info.fda.gov/e/er?utm%5Fcampaign=SBIA%3A%20FDA%20updates%20summary%20table%20forms%20for%20ANDA%20submissions%20containing%20clinical%20endpoint%20studies&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=6464&elqTrackId=5D5B7080E137AB0A775C2F50AB7EEAAD&elq=3b87068d8260476e907a05b80131f74f&elqaid=6712&elqat=1) (for transdermal and topical delivery systems). Additionally, the [summary table forms for aqueous nasal spray products](http://app.info.fda.gov/e/er?utm%5Fcampaign=SBIA%3A%20FDA%20updates%20summary%20table%20forms%20for%20ANDA%20submissions%20containing%20clinical%20endpoint%20studies&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=6454&elqTrackId=6251CD606A28CD0E5F4A7EA031193FD1&elq=3b87068d8260476e907a05b80131f74f&elqaid=6712&elqat=1) have been updated. The new version includes updated summary tables for six *in vitro* studies and batch information based on the revised Nasal Product Specific Guidances, as well as updated summary tables for pre-study method validation and formulation tables.