LEADER 01318nam  2200349Ia 450 
001 9910699281003321
005 20230902162120.0
035   $a(CKB)5470000002401093
035   $a(OCoLC)471897730
035   $a(EXLCZ)995470000002401093
100   $a20091201d2004      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $elisted drugs, 30 month stays, and approval of ANDAs and 505(b)(2) applications under Hatch-Waxman, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, questions and answers
210  1$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 (12 pages)
300   $a"Draft guidance."
300   $a"OGD."
300   $a"October 2004."
517   $aGuidance for industry 
606   $aDrug approval$zUnited States
615  0$aDrug approval
712 02$aCenter for Drug Evaluation and Research (U.S.).$bOffice of Generic Drugs.
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910699281003321
996   $aGuidance for industry$93434577
997   $aUNINA