Page 6 - Orange Book Cumulative Supplement 10 October 2012
P. 6

	  Patent information, also updated daily in the EOB, is current to
                          the date of publication.

                          	  Exclusivity information is updated monthly and current to the date of
                          publication.

                     Every effort is made to ensure the Cumulative Supplement is current and
                     accurate.  Applicant holders are requested to inform the FDA Orange Book
                     Staff (OBS) of any changes or corrections. The OBS can be contacted by
                     email at drugproducts@fda.hhs.gov.  Send Changes by FAX:  240-276-8974;
                     mail to:

                                            FDA/CDER Orange Book Staff
                                            Office of Generic Drugs, HFD-610
                                            7620 Standish Place
                                            Rockville, MD 20855-2773


               1.3   APPLICANT NAME CHANGES

                     It is not practical to identify in the Cumulative Supplement each and
                     every product involved when an applicant transfers its entire line of
                     approved drug products to another applicant, or when an applicant changes
                     its name.  Therefore, the cumulation of these transfers and name changes
                     will be identified in this section only.  Where only partial lines of
                     approved products are transferred between applicants, each approved
                     product involved will appear as an applicant name change entry in the
                     Cumulative Supplement.

                     It is also not practical to identify each and every product involved when
                     an applicant name is changed to meet internal publication standards
                     (e.g., MSD or Zenith [Former Abbreviated Names] are changed, respectively
                     to Merck Sharp Dohme or Zenith Labs [New Abbreviated Names]).  When this
                     occurs, each product involved (either currently in the Cumulative
                     Supplement or in the following year's edition) will reflect the new
                     abbreviated name.  Consequently, it will not appear as an applicant name
                     change entry in the Cumulative Supplement nor will the cumulation of
                     these name changes appear in this section.  The Electronic Orange Book
                     Query, updated monthly, will contain the most current applicant holder
                     name.

                         FORMER APPLICANT NAME                         NEW APPLICANT NAME
                           (FORMER ABBREVIATED NAME)                     (NEW ABBREVIATED NAME)


                      ABBOTT LABORATORIES                              ABBVIE INC
                          (ABBOTT LABS)                                   (ABBVIE)

                          (ABBOTT)         	                              (ABBVIE)

                      ABBOTT LABORATORIES HOSP PRODUCTS DIV           ABBVIE INC
                          (ABBOTT)                                        (ABBVIE)

                      ABBOTT LABORATORIES PHARMACEUTICAL               ABBVIE INC
                          (ABBOTT)                                        (ABBVIE)

                      ABBOTT PRODUCTS                                  ABBVIE INC
                          (ABBOTT)                                        (ABBVIE)

                      ABRAXIX PHARMACEUTICAL PRODUCTS                  FRESENIUS KABI USA LLC
                          (ABRAXIS PHARM)                                 (FRESENIUS KABI USA)

                      ALCON UNIVERSAL LTD                              ALCON PHARMACEUTICALS LTD
                          (ALCON UNIVERSAL)                               (ALCON PHARMS LTD)


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