01151nam 2200337Ia 450 991069692000332120230902161731.0(CKB)5470000002383695(OCoLC)560270393(EXLCZ)99547000000238369520100319d2004 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changesRockville, MD :U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,[2004]1 online resource (2 pages)"CMC.""November 2004."Guidance for industry Drug approvalUnited StatesDrug approvalCenter for Drug Evaluation and Research (U.S.)GPOGPOBOOK9910696920003321Guidance for industry3434577UNINA