USFDA generic approval process

Indian Journal of Pharmaceutical Education and Research

Volumn 43, Issue 3, 2009, Pages 232-240

  Saigal, Nitin ^a   Baboota, Sanjula ^a   Ahuja, Alka ^a   Ali, Javed ^a  

^a HAMDARD UNIVERSITY   (India)

Author keywords

ANDA; Anda Para certifications; Bioequivalence; Brand name manufacturer; f2 value; Generic; Generic Manufacturer; Hatch Waxman Act; Infringement; Innovator; Lawsuit; NDA

Indexed keywords

GENERIC DRUG;

BIOEQUIVALENCE; DRUG APPROVAL; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; LAW; REVIEW; UNITED STATES;

EID: 70349086911     PISSN: 00195464     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

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