federal_register: E8-23721

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
E8-23721 Withdrawal of Approval of 128 Suitability Petitions; Correction Notice The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 23, 2007 (72 FR 8184). The notice announced that FDA was withdrawing approval of 128 suitability petitions in accordance with the Pediatric Research Equity Act of 2003 (PREA). FDA has determined that approval of the suitability petition submitted by Roxane Laboratories, Inc. (Roxane), for lorazepam oral solution, 1 milligram (mg)/10 milliliters (mL) (Docket No. FDA- 1994-P-0017),\1\ should not have been withdrawn and therefore retroactively reinstates its approval of that petition. This document also corrects errors in the petition numbers for two of the suitability petitions listed in the notice. --------------------------------------------------------------------------- 2008-10-07 2008 10 https://www.federalregister.gov/documents/2008/10/07/E8-23721/withdrawal-of-approval-of-128-suitability-petitions-correction https://www.govinfo.gov/content/pkg/FR-2008-10-07/pdf/E8-23721.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 23, 2007 (72 FR 8184). The notice announced that FDA was withdrawing approval of 128 suitability petitions in accordance with the Pediatric...  

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