Date Field | Doc. No. | Party | Description |
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Jan 13, 2017 | 1067 | | April 21, 2003 Resp. to Office Action dated March 4, 2003, App. No. 09/807,462 Download |
Jan 13, 2017 | 1066 | | Approval Letter from Russell Katz, M.D., Director, Div. of Neuropharm. Drug Products, Office of Drug Eval., to Tami Martin, Vice Pres. of Reg. Affairs, Shire Labs., Inc. (Oct. 11, 2001)(on file at http://www.accessdata.fda.gov/drugsatfda_docs/....pdf) Download |
Jan 13, 2017 | 1065 | | Approval Letter from Robert Temple, M.D., Director, Office of Drug Eval., to William A. Nuerge, Chief Oper. Officer, Richwood Pharm. Co., Inc. (Feb. 13, 1996)(on file at http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/11522S010_Adderall.pdf) Download |
Jan 13, 2017 | 1064 | | Charles W. Popper, M.D., The Story of Four Salts, JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGY vol. 4, n. 4 (1994) Download |
Jan 13, 2017 | 1063 | | U.S. Patent No. 1,921,424 Download |
Jan 13, 2017 | 1062 | | U.S. Patent No. 1,879,003 Download |
Jan 13, 2017 | 1061 | | Edward Stempel, Dispensing of Medication (Eric W. Martin ed., 7th ed., 1971) Download |
Jan 13, 2017 | 1060 | | James R. McCowan, Dispensing of Medication (Eric W. Martin ed., 7th ed., 1971) Download |
Jan 13, 2017 | 1059 | | Handbook of Pharmaceutical Excipients (Ainley Wade & Paul J. Weller, ed., 2d ed., 1994) Download |
Jan 13, 2017 | 1058 | | W. H. Hartung & J. C. Munch, Amino Alcohols, VI. The Preparation and Pharmacodynamic Activity of Four Isomeric Phenylpropylamines, 53 J. AM. CHEM. SOC. (1931) Download |
Jan 13, 2017 | 1057 | | 1995 United States Pharmacopeia and National Formulary, USP 23-NF (1994) Download |
Jan 13, 2017 | 1056 | | Stuart C. Porter, Remington: The Science and Practice of Pharmacy (19th ed., 1995) Download |
Jan 13, 2017 | 1055 | | Charles S.L. Chiao & Joseph R. Robinson, Remington: The Science and Practice of Pharmacy (19th ed., 1995) Download |
Jan 13, 2017 | 1054 | | Brian B. Hoffman & Robert J. Lefkowitz, Goodman & Gilman's The Pharmacological Basis of Therapeutics (9th ed., 1996) Download |
Jan 13, 2017 | 1053 | | Patricia K. Sonsalia, Remington: The Science and Practice of Pharmacy (19th ed., 1995) Download |
Jan 13, 2017 | 1052 | | 1997 Physicians' Desk Reference (51st ed., 1997) Download |
Jan 13, 2017 | 1051 | | 1995 Physicians' Desk Reference (49th ed., 1994) Download |
Jan 13, 2017 | 1050 | | 1993 Physicians' Desk Reference (47th ed., 1992) Download |
Jan 13, 2017 | 1049 | | 1974: Physicians' Desk Reference (28th ed., 1974) Download |
Jan 13, 2017 | 1048 | | Simon J. Tulloch, et al., SLI381 (Adderall XR), a Two-Component, Extended-Release Formulation of Mixed Amphetamine Salts: Bioavailability of Three Test Formulations ..., PHARMACOTHERAPY vol. 22 (2002) Download |
Jan 13, 2017 | 1047 | | Adderall Immediate Release ("IR") Medication Guide Download |
Jan 13, 2017 | 1046 | | Ansel, Popovich & Allen, Pharmaceutical Dosage Forms and Drug Delivery Systems (6th ed., 1995) Download |
Jan 13, 2017 | 1045 | | Susan B. Clausen, Single- and multiple-dose pharmacokinetics of an oral mixed amphetamine salts extended-release formulation in adults, CNS SPECTRUMS vol. 10 (Dec. 2005) Download |
Jan 13, 2017 | 1044 | | The Merck Index, (Susan Budavari, ed., 11th ed., 1996) Download |
Jan 13, 2017 | 1043 | | July 2005 Package Insert for Adderall Extended Release ("XR") Download |
Jan 13, 2017 | 1042 | | August 2005 Package Insert for Adderall Immediate Release ("IR") Download |
Jan 13, 2017 | 1041 | | Adderall XR Medication Guide Download |
Jan 13, 2017 | 1040 | | Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations: Patent and Exclusivity for: N021303 Download |
Jan 13, 2017 | 1039 | | OPADRY Manufacturer Poster Download |
Jan 13, 2017 | 1038 | | The '066 application, Patent Publication No. 2007/0264323 Download |
Jan 13, 2017 | 1037 | | U.S. Patent No. RE42,096 Download |
Jan 13, 2017 | 1036 | | SURERELEASE Product Brochure Download |
Jan 13, 2017 | 1035 | | U.S. Patent No. 5,474,786 Download |
Jan 13, 2017 | 1034 | | U.S. Patent No. 4,904,476 Download |
Jan 13, 2017 | 1033 | | U.S. Patent No. 4,794,001 Download |
Jan 13, 2017 | 1032 | | U.S. Patent No. 4,728,512 Download |
Jan 13, 2017 | 1031 | | U.S. Patent No. 8,313,776 Download |
Jan 13, 2017 | 1030 | | U.S. Patent No. 5,326,570 Download |
Jan 13, 2017 | 1029 | | U.S. Patent No. 6,555,136 Download |
Jan 13, 2017 | 1028 | | U.S. Patent No. 8,906,413 Download |
Jan 13, 2017 | 1027 | | U.S. Patent No. 5,837,284 Download |
Jan 13, 2017 | 1026 | | U.S. Patent Application Publication No. 2004/0197405 Download |
Jan 13, 2017 | 1025 | | U.S. Patent No. 5,407,686 Download |
Jan 13, 2017 | 1024 | | U.S. Patent No. 2,738,303 Download |
Jan 13, 2017 | 1023 | | U.S. Patent No. 6,913,768 Download |
Jan 13, 2017 | 1022 | | "Adderall XR," Drugs@FDA (http://www.accessdata.fda.gov/) Download |
Jan 13, 2017 | 1021 | | "Adderall," Drugs@FDA (http://www.accessdata.fda.gov/) Download |
Jan 13, 2017 | 1020 | | C. Bradley, The Behavior of Young Children Receiving Benzedrine, AM. J. PSYCHIATRY, vol. 94, 154-162 (1937) Download |
Jan 13, 2017 | 1019 | | Christopher J. Kratochvil, ADHD: Treatment and Outcome, MANAGING ADHD, vol. 4 (3A) (2004) Download |
Jan 13, 2017 | 1018 | | Declaration of Edmund J. Elder, Jr., Ph.D., R.Ph. Download |
Jan 13, 2017 | 1017 | | The '066 application, Notice of Allowance and Allowability, 7-7-2014 Download |
Jan 13, 2017 | 1016 | | The '066 application, fifth Response, 6-3-2014 Download |
Jan 13, 2017 | 1015 | | The '066 application, fifth Office Action, 4-30-2014 Download |
Jan 13, 2017 | 1014 | | The '066 application, fourth Response, 1-24-2014 Download |
Jan 13, 2017 | 1013 | | The '066 application, fourth Office Action, 10-07-13 Download |
Jan 13, 2017 | 1012 | | The '066 application, third Response, 1-12-2011 Download |
Jan 13, 2017 | 1011 | | The '066 application, third Office Action, 10-12-10 Download |
Jan 13, 2017 | 1010 | | The '066 application, second Response, 7-28-10 Download |
Jan 13, 2017 | 1009 | | The '066 application, second Office Action, 4-30-10 Download |
Jan 13, 2017 | 1008 | | The '066 application, first Response, 1-29-10 Download |
Jan 13, 2017 | 1007 | | The '066 application, first Office Action, 10-2-09 Download |
Jan 13, 2017 | 1006 | | The '066 application, second preliminary amendment, 10-26-06 Download |
Jan 13, 2017 | 1005 | | The '066 application, first preliminary amendment, 10-24-06 Download |
Jan 13, 2017 | 1004 | | Original application 11/383,066 (the '066 application) Download |
Jan 13, 2017 | 1003 | | U.S. Patent No. 6,605,300 (the '300 patent) Download |
Jan 13, 2017 | 1002 | | U.S. Patent No. 6,322,819 (the '819 patent) Download |
Jan 13, 2017 | 1001 | | U.S. Patent No. 8,846,100 (the '100 patent) Download |
May 2, 2017 | 8 | | Termination Decision Document Download |
Apr 26, 2017 | 7 | | Request to File Settlement Agreement as Business Confidential Information Pursuant to 35 U.S.C. 317 and 37 C.F.R. 42.74(c) Download |
Apr 26, 2017 | 6 | | Joint Notice of Settlement, Request to Terminate and Request to Keep Separate Under 37 C.F.R. 42.74 (c) Download |
Feb 3, 2017 | 5 | | Patent Owner Mandatory Notices under 37 C.F.R. 42.8(a)(2) Download |
Feb 3, 2017 | 4 | | Patent Owner Power of Attorney under 37 C.F.R. 42.10(b) Download |
Feb 2, 2017 | 3 | | Notice of Accord Filing Date Download |
Jan 13, 2017 | 2 | | Petitioner's Power of Attorney for Inter Partes Review of U.S. Patent No. 8,846,100 Download |
Jan 13, 2017 | 1 | | Petition for Inter Partes Review of U.S. Patent No. 8,846,100 Under 35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.100 et. seq. Download |