U.S. FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
245. Tamsulosan 17-11-08
+ Tolterodine (0.4mg MR Pellets
+ 2mg/4mg ER pellets) Capsules
(Addl/Lower stgth)
Benign prostatic cancer
U.S FDA APPROVED DRUGS DURING 2006
3. Combikit of Tamsulosan Hcl 19-01-2006
0.4mg MR capsule (10 nos.) &
Dutaseride Soft Gelatin Capsule
0.5mg (10no.s)
For BPH
6. Tamsulosin HCL (MR) 0.4mg + 19-01-2006
Dutaseride 0.5mg tablet For BPH
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Tamusulosin HCl alpha- Adrenooreceptor 04-04-2002
antagonist for BPH
2.Combikit of Tamsulosin Hcl 0.4mg 19-01-2006
M.R.Capsule (10no.) + Dutasteride
Soft Gelatin capsules 0.5mg (10 no.)
For BPH
3.Tamsulosin + Tolerodine 17-11-2008
( 0.4mg MR Pellets + 2mg/4mg ER Pellets)
Capsules
Addl.Lower stgth
BPH
4. Tamsulosin Hcl MR 0.4mg 06-02-2006
+ Dutasteride 0.5mg Tablet
For BPH
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Tamsulosan (0.4mg MR pellets+ 17-11-2008
Tolterodine 2mg/4mg ER pellets)
capsules
For BPH with overaction in Adults only
2. Tamsulosan 0.4mg + 17-03-2004
Finastride 5mg MR capsule
For the treatment of signs and symptoms of Benign
Prostatic Hyperplasia (BPH)
3.Tamsulosan HCL MR 0.4mg + 06-02-2006
Dutsteride 0.5mg tablet
For BPH
4.Tamsulosin HCL 0.4mg + 08-10-2008
Tolerodine tartrate 2mg ER capsule