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Food & Drug Regulations › Abbreviated New Drug Application (ANDA) › Food and Drug Administration (FDA)

Robins Kaplan LLP

Generic Launches Second Quarter 2025

Robins Kaplan LLP on

This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more

Robins Kaplan LLP

Generic Launches - Abbreviated New Drug Applications and 505(b)(2) Applications

Robins Kaplan LLP on

This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more

McDermott Will & Schulte

FDA Publishes Proposed Rule on Sections 503A and 503B Compounding

McDermott Will & Schulte on

On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more

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