Approved by FDA on January 18, 1996
U.S FDA APPROVED DRUGS APPROVED FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
20. Cefepime (as hydrochloride) 2000/1000/500mg 24-01-08
+ Sulbactam (as sodium) 1000/500/250mg
per vial of injection
For serious CRTI,uncomplicated and complicated skin &
structure, infection acute exacerbation of chronic bronchtis
& intraabdominal infection
U.S. FDA APPROVED DRUGS DURING 2006
103. Cefepem (as HCL) 0.5/1gm 11-08-2006
+Amikacin (as sulphate) 0.125/0.250gm inj
antibiotic
133. Cefipime (as HCL) 500mg/1000mg 30-08-2006
+Tazobactum (as sodium) 62.5mg/125mg
per vial injection Antibiotic U.S.FDA APPROVED DRUGS DURING 2007
88. Cefepime injection 500mg/1gm/2gm 14-06-07
(For addtl.indication)
For bacterial meningitis in children
94. Cefepime Injection 14-06-07
(New indication)
For bacterial meningitis in children
118. Cefepime (250mg) 30-07-07
+Tazobactum 931.25mg) injection
(Addl.stgth)
As approved
Urinary tract infections
Drugs covered:
1st generation 2nd generation 3rd generation .
Cephalexin Cefaclor Cefixime Cefadroxil Cefamandole Cefoperazone Cephadrine Cefotoxitin Cefotaxime Cephalothin Cefuroxime Ceftizoxime Cephapirin Cefonicid Ceftriaxone Cefazolin Cefmetazole Ceftazidime Cefotetan Ceftibuten Cefprozil Cefepime Cefpodoxime Loracarbef
Refer Cephalosporins
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1. Cefepime as Hcl 0.5/1gm + Amikacin 11-06-2006
as sulphate 0.125/0.250gm inj
Antibiotic
2. Cefepime 250mg + Tazobactum 30-07-2007
31.25mg injection ( Addl.strength)
Same as approved
3.Cefepime as HCl 500mg/1000mg + 30-08-2006
Tazobactum as sodium 62.5mg/125mg
Antibiotic
4. Cefepime as Hcl 2000/1000/500mg + 24-01-2008
Sulbactum as sodium 1000/500/250mg
per vial of injection
For serious CRTI.uncomplicated and complicated UTI,
uncomplicated skin & skin structure exacerbation of
chronic bronchitis & and intra-abdominal infection
5. Cefipime injection 500mg/1gm/2gm 14-06-2007
For bacterial menigintis in children
(Addl.indication)
6. Cefipime Hcl 30-10-2002
Antibiotic
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Cefepime Hcl 0.5/1gm+ 08-11-2006
Amikacin sulphate 0.125/0.25gm injection
Antibiotic
2.Cefepime 250mg+ 30-07-2007
Tazobactam 31.25mg injection
Addl.Stgth
For the treatment of uncomplicated and compilacated UTI, uncomplicated
skin structure infections and complicated intra-abdominal infections
Addl.Indication-
LRTI including pneumonia & Bronchitis , septicaemia, empirc treatment in
febrile neurotropenic patients
3.Cefepime Hcl 500mg/1000mg+ 30-08-2006
Tazobactum as Sodium 62.5mg/125mg per injection
For the treatment of uncomplicated and compilacated UTI, uncomplicated
skin structure infections and complicated intra-abdominal infections
Addl.Indication-
LRTI including pneumonia & Bronchitis , septicaemia, empiric treatment in
febrile neurotropenic patients
4.Cefepime Hcl 2000/1000/500mg + 24-01-2008
Subactum as Sodium 1000/500/250mg per vial injection
For seroius CRTI ,uncomplicated and complicated UTI, uncomplicated
skin and skin structure , infection acute exacerbation of chronic
bronchitis & intraabdominal infection
