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Title Guidance for industry [electronic resource] : alternate source of the active pharmaceutical ingredient in pending ANDAs.

Imprint Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2000]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:AC 8    ---  Available
Description 1 online resource (3 p.)
Note "Office of Generic Drugs."
"December 2000."
Subject Drugs -- Generic substitution -- Government policy -- United States.
Drug approval -- United States.
Added Author Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs.
Added Title Alternate source of the active pharmaceutical ingredient in pending ANDAs
Gpo Item No. 0499-T (online)
Sudoc No. HE 20.4702:AC 8

 
    
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