U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
13. Ceftazidime 500mg 08-01-08
+ Tobramycin 60mg/per vial injection
For the treatment of lower respiratory infection
caused by pseudonomas arguginosa
170. Ceftazidime 05-08-08
+ Tobramycin injection (1gm+ 120mg)
(Addl. stgth)
same as approved
267. Ceftazidime 24-12-08
+ Sulbactum (500mg/1000mg)
+ 250/500mg Injection
i. For LRTI in infections
ii. For UTI -complicated and uncomplicated
iii. For bacterial septicemia
iv. For bone and joint infections
v. For gynaecologic infections including endometritis,
pelvic cellulitis, and other infections of female genital tract
vi. For CNS infections including meningitis
U.S FDA APPROVED DRUGS DURING 2006
132. Ceftazidime 500mg/1000mg 30-08-2006
+Tazobactum (as sodium) 62.5mg/125mg per vial
injection Antibiotic
U.S.FDA APPROVED DRUGS DURING 2007
79. Ceftazidime 500mg/1000mg 08-06-07
+Sulbactum (as sodium) 250mg/500mg/
For injection
Antibiotic
129. Ceftazidime (2gm) 06-09-07
+Sulbactum (1 gm) injection
(addl.stgth for addl.indication)
For serious abdominal infection
U.S.FDA APPROVED DRUGS DURING 2007
79. Ceftazidime 500mg/1000mg 08-06-07
+Sulbactum (as sodium) 250mg/500mg/
For injection
Antibiotic
129. Ceftazidime (2gm) 06-09-07
+Sulbactum (1 gm) injection
(addl.stgth for addl.indication)
For serious abdominal infection
A 3rd generation drug
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1. Cefazidime Antibiotic June 1988
pentahydrate
2. Ceftazidime + Sulbactum 500mg/1000mg 24-12-2008
+ 250mg/500mg injection
i.For LRTI infections
ii. For UTI complicated and uncomplicated
iii. For Bacterial septecemia
iv. For Bone and joint infections
v. For Gynaecologic infections including endometritis, Pelvic
cellulitis and other infections of genital tract
vi. For CNS infections including menigitis
3. Ceftazidime + Tobramycin injection 05-08-2008
1gm + 120mg - Addl.strgth
same as approved
4. Ceftazidime 500mg /1000mg + 30-08-2006
Tazobactum sodium
62.5mg/125mg per vial for injection
Antibiotic
5. Ceftazidime 500mg + Tobramycin 08-01-2008
60mg per vial injection
For the treatment of lower respiratory tract infection caused
by pseudomonas aeroginosa
6. Ceftadimine 500mg/1000mg + 08-06-2007
Sulbactum sodium 250mg/500mg
for injection
Antibiotic
7. Ceftazidine 2gm + Sulbactum 1gm 06-09-2007
Injection - Addl.stgth. for
Addl.Indication
For serious abdominal infection
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Ceftazidime 250mg+ 31-07-2007
Tazobactum 31.25mg injection
Addl.Stgth
For the treatment of hospital acquired infection like nosocomal
pneumonia, uncomplicated skin and skin structure 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
