U.S.FDA  APPROVED DRUGS FROM 01-01-08 TO 31-12-08

 

Drug name                               Indication                  Date of Approval

 

6. Citicholine syrup 750mg/5ml                                      04-01-08

    For the treatment of disturbances of consciousness                          

    resulting from head injuries, brain operation and acute

    stage of cerebral  infarction in adults only

 

176. Citicoline Chewable tablet 500mg                      18-08-08

    For the treatment of disturbance of consciouness 

    as  resulting from head injuries, brain, oeration 

   and acute stage of cerebral  infraction in adult only

 

200. Citicholine CR Tab 1000mg                               16-09-08

       For the treatment of patients with serious 

       cerbral  injuries of vascular traumatic nature 

       with or without  loss of  consciousness damages

      & chronic cerebral  vascular injuries in senile dementia 

 

212. Citicholine Oral drops                                     30-09-08

       For the treatment of disturbance of 

      consciousness  resulting from head injuries,

      brain operation & acute  stage of cerbral i

      nfarction in adult

 

231. Citicholine Troches 200/500mg                       31-10-08

        For the treatment of patients with serious

        cerbral injuries  of vascular traumatic nature 

        with or without  loss of consciousness and for 

        treatment of degenarative  damages and 

        chronic cerbral vascular injuries in senile

        dementia 

  

U.S.FDA APPROVED DRUGS DURING 2004

 

227. Citicholine Tablet 500mg &                20-08-2004

        Injection 250mg/ml

        Membrane permeability enhancer

 

U.S.FDA APPROVED  DRUGS DURING 2007

 

 51. Citicoline (750mg) tablet(addl.stgth),             10-04-07 

        Syrup 500mg/ml (New dosage form)

       (Not for children) 

        As approved 

 

75.  Citicoline tablet 200mg                      25-05-07 

        (addl.stgth)

        As approved 

 

169. Citicoline (as Sod.) 200mg/500mg/750mg    26-11-07 

        granules per sachet  

         As approved 

 

New drugs approved For Marketing by Drug Controller General of India(DCGI )

                          during the period January 1988 to November 2014

                             (Ref- IDMA Annual Publication 2015)

 

Name of Drug                          Indication                               Date of Approval

 

1.Citicholine 500mg +Piracetam                                           16-03-2010

  400mg tablets

 

   For the treatment of acute stroke

 

2. Citicholine syrup 750mg/5ml                                             04-01-2008

 

   For the treatment of disturbance of consciousness resulting from

  head injuries, brain operation, and acute stage of cerebral 

  infarction  in adults only

 

3. Citicholine sodium                                                            26-11-2007

   200mg/500mg/750mg granules per sachet

 

   As approved

 

4. Citicholine 750mg  tablet                                                 10-04-2007

  Addl. stgth  syrup 500mg/5ml

  New dosage form

  Not for children 

 

  As approved

 

5. Citicholine 500mg+ Piracetam                                      11-10-2010

   400mg per 5ml syrup

    Addl.dosage form

 

   As approved

 

6. Citicholine chewable tablet                                          18-08-2008

    500mg

 

    For the treatment of disturbance of consciousness as resulting

   from head injuries, brain operation and acute stage of cerebral

   infraction in adult only 

 

7.Citicholine CR tablet 100mg                                           16-09-2008

 

   For the treatment of patients with serious cerebral injuries of

  vascular traumatic nature with or without loss of consciousness

  and for treatment of degenerative damages and chronic cerebral

  vascular injuries 

 

8.Citicholine oral drops                                                      30-09-2008

 

   For the treatment of disturbances of consciousness resulting 

  from head injuries, brain operation, and acute stage of cerebral

  infraction in adults only

 

9. Citicholine tablet 200mg                                                  25-05-2007

    Addl.Stgth

 

    As approved

 

10. Cicholine troches 200/500mg                                      31-10-2013

 

  For the treatment of patients with serious cerebral injuries of

  vascular traumatic nature with or without loss of consciousness

  and for treatment of degenerative damages and chronic cerebral

  vascular injuries in senile dementia