Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
101. Dexketoprofen ( as trometamol ) tablets 28-03-08
12.5mg/25mg
For the treatment of mild to moderate pain,
such as dental pain,dysmenorrhoea &
musculoskeltal pain
Mild to moderate pain Musculo-skeltal pain Dysmenorrhea Dental pain
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1. Dexketoprofen Tremetamol Tablets 28-03-2008
12.5mg/25mg
For the treatment of mild to moderate pain, such as dental pain,
Dysmenorrhoea, & musculoskeletal pain.
2.Dexketoprofen 12.5mg /25mg + 18-05-2009
Paracetamol 500mg film coated tablets
For the treatment of acute musculoskeletal pain
3.Dexketoprofen 50mg + Dicyclomine 28-04-2011
20mg per2ml ijection
For the treatment of acute colilky pain in adults
4.Dexketoprofen Trometamol 25mg + 20-05-2010
Thiocolchicoside 4mg tablets
For the trestment of acute low back pain and other musculoskeletal
painful & inflammatory conditions in adult patients
5. Dexketoprofen Trometamol ER 21-02-2011
tablet 50mg - Addl.Stgth
Same as approved
6.Dexketoprofen Trometamol Gel 13-10-2009
12.5mg/gm
For the painful and inflammatory conditions associated with
joints, Tendons, Ligaments, and muscle
7.Dexketoprofen Trometamol 22-10-2009
injection 50mg/ml
Symptomatic treatment of acute pain of moderate to severe intensity
when oral administration not appropiate such as post-operative pain,
renal colic, and low back pain
8.Dexketoprofen 25%w/w + 06-07-2010
linseed oil 3.0% w/w + Menthol 5%w/w
+ Methyl salicylate 10% w/w 12.5mg
For the topical treatment of acute musculoskeletal pain
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
1.Dexketoprofen 1.25%w/w + 07-06-2010
Linseed oil 3.0% w/w
Menthel 5% w/w +
Methyl salicylate 10% w/w 12.5mg Gel
For the tropical treatment of acute musculoskeletal pain