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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