United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2016-10-17 article Notices D09002ee1c7f34f4d D09002ee1c7f34fe4 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for methylphenidate hydrochloride (HCl) extended-release (ER) tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal. 81 FR 71741 https://www.govinfo.gov/app/details/FR-2016-10-18/2016-25092 2016-25092 fr18oc16-77 4164-01-P Docket No. FDA-2016-N-3120 https://www.govinfo.gov/app/details/FR-2016-10-18/2016-25092 https://www.govinfo.gov/content/pkg/FR-2016-10-18/html/2016-25092.htm https://www.govinfo.gov/content/pkg/FR-2016-10-18/pdf/2016-25092.pdf 5 p. 71741 71745 81 FR 71741 Kremers Urban Pharmaceuticals Inc.; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets; Opportunity for a Hearing; Federal Register Vol. 81, Issue NOTICE 2016-25092 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-12-19 2016-11-17 Docket No. FDA-2016-N-3120 4164-01-P 2016-25092 Notice.

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for methylphenidate hydrochloride (HCl) extended-release (ER) tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal.

Kremers Urban Pharmaceuticals Inc., may submit a request for a hearing by November 17, 2016. Submit all data, information, and analyses upon which the request for a hearing relies by December 19, 2016. Submit written or electronic comments by December 19, 2016. Maryll W. Toufanian, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1716, Silver Spring, MD 20993-0002, 240- 402-7944. Abbreviated New Drug Applications: Kremers Urban Pharmaceuticals Inc.; Extended-Release Methylphenidate Tablets; Withdrawal , http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm126391.htm http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM320007.pdf http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377465 http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov Vol. 81, no. 201 Office of the Federal Register, National Archives and Records Administration 2016-10-18 continuing daily deposited born digital 414 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-10-18 P0b002ee191ba789a 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr18oc16 https://www.govinfo.gov/app/details/FR-2016-10-18 https://www.govinfo.gov/content/pkg/FR-2016-10-18/pdf/FR-2016-10-18.pdf https://www.govinfo.gov/content/pkg/FR-2016-10-18/xml/FR-2016-10-18.xml fdlp 71571 71975 DGPO 2016-10-17 2024-06-01 FR-2016-10-18 machine generated eng FR FR-2016-10-18 81 201