Examples of ANDA in a sentence

Please note that if FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for a listed drug, an ANDA citing that listed drug also will be required to have a REMS.
Bidders may be required to submit a copy of the NDA or ANDA approval letter or approval number and date of approval before or during the contract award.
On August 13, 2018, the Company announced that the FDA has approved its ANDA for SNP, a generic intravenous cardiovascular product and the product became available commercially during the third quarter of 2019.
For all items, with FDA required 'New Drug Applications' or 'Abbreviated New Drug Applications', manufacturers shall hold an NDA or ANDA, which shall be in effect at the time of the bid.
In such a case, the appropriate submission would be an Abbreviated New Drug Application (ANDA) that cites the duplicate product as the reference listed drug.

More Definitions of ANDA

ANDA means an Abbreviated New Drug Application filed pursuant to the requirements of the FDA, or the equivalent application in any other country or jurisdiction, required before Commercial Sale of a drug product.

ANDA means an Abbreviated New Drug Application, or similar application for marketing approval of a Product submitted to the FDA.

ANDA means an abbreviated new drug application submitted to the FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act and any amendments or supplements thereto.

ANDA means an Abbreviated New Drug Application as defined in the FD&C Act and the regulations promulgated thereunder which references an NDA.