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035   $a(CKB)5470000002383695
035   $a(OCoLC)560270393
035   $a(EXLCZ)995470000002383695
100   $a20100319d2004      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $echanges to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes
210  1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,$d[2004]
215   $a1 online resource (2 pages)
300   $a"CMC."
300   $a"November 2004."
517   $aGuidance for industry 
606   $aDrug approval$zUnited States
615  0$aDrug approval
712 02$aCenter for Drug Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910696920003321
996   $aGuidance for industry$93434577
997   $aUNINA