01318nam 2200349Ia 450 991069928100332120230902162120.0(CKB)5470000002401093(OCoLC)471897730(EXLCZ)99547000000240109320091201d2004 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] listed 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 answersRockville, MD :U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,[2004]1 online resource (12 pages)"Draft guidance.""OGD.""October 2004."Guidance for industry Drug approvalUnited StatesDrug approvalCenter for Drug Evaluation and Research (U.S.).Office of Generic Drugs.GPOGPOBOOK9910699281003321Guidance for industry3434577UNINA