FDA In Brief: FDA issues 57 product-specific guidances, including 19 laying out path for developing generics to hard-to-copy “complex” medicines

The results of research studies conducted GDUFA initiatives provide new tools for FDA to evaluate generic drug equivalence.

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/13/2025
Short Title (70 char) Pharmcore Inc. dba Hallandale Pharmacy. Fort Lauderdale, FL. 483 issued 06/13/2025
FEI Number 3014480778
Firm Name Pharmcore Inc. dba Hallandale Pharmacy
Record Type 483
State FL

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Lupin Limited Unit 3 – 07/17/2025. Country: India. Record Type: 483

Unapproved New Drugs/Misbranded/Botox

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet