Indication:
U.S. FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
29. Diclofenac 50mg 24-01-08
+ Serratiopeptidase 10mg enteric coated tabs
For the treatment of acute pain in adults
38. Diclofenac sodium 50mg 28-01-08
+Dicyclomine HCL 20mg per ml injection
For the treatment of acute coliky pain in adults
57. Diclofenac sodium 50mg 30-01-08
Paracetamol 500mg
For the symptomatic treatment of acute pain
inflammation in patients with osteoarthiritis,
rheumatoid arthiritis and ankylosing spondylolitis
73.Diclofenac Sodium 100mg (SR Pellets) 31.01-08
+ Rabeprazole Sodium 20mg (EC Pellets)
Capsules
For treatment of painful inflamatory conditions
associated with gastroduodenal ulcers
144. Diclofenac Sodium 50mg 02-06-08
+ Codeine Phosphate 50mg tablets
For the treatment of adult patients with signs &
symptoms of acute painful conditions
228. Diclofenac 21-10-08
+ Thiocolochicolate (50mg EC+8mg)
Capsules
For the treatment of acute inflammation conditions
associated with spasm in adults only
270. Diclofenac 24-12-08
+ Thiocolchicoside (50mg+ 4mg)
Capsules
(Addl.lower Stgth)
U.S FDA APPROVED DRUGS DURING 2004
221. Diclofenac Transdermal patch 100mg/50cm2 10-08-2004
For Osteoarthiritis & soft tissue injury
244. Diclofenac Transedermal Patch 06-10-2004
(200mg/75cm2)
For pain relief
U.S FDA APPROVED DRUGS DURING 2006
23. Diclofenac Sodium 975/50mg) as EC + 28-02-2006
+ Misoprostol 200mcg
For OA & RA
U.S FDA APPROVED DRUGS DURING 2007
115. Diclofenac Sodium (75mg/ml) 30-07-07
injection(addl.stgth)
For management of painful conditions in
post-operative cases,rheumatoid arthiritis
and osteoarthiritis
Approved by (DCI) Drug Controller GENERAL - India For Marketing (Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Diclofenac EC Tabs 25mg+ 31-05-2011
paracetamol 325mg capsule
Addl.stgth
Same as approved
2.Diclofenac colystyramine 145mg 25-02- 2013
Capsule corresponding to
Diclofenac sodium 75mg
Addl.:Indication
For the treatment of post-traumatic or post-operative swelling and
Inflammation
3.Diclofenac Diethylamine BP 4.64% 21-12-2012
w/v equiv. to Diclofenac sodium IP 4%
+ absolute alcohol IP 10% v/v topical solution
For the treatment of Acute lower back pain
4.Diclofenac Sodium Injecction 75mg/2ml 04-12-2012
For acute painful conditions in post operative pain , renal colic
and acute exacerbation of Gouty arthiritis
5. Diclofenac + Thiocolchicoside 24-12-2008
50mg+ 4mg Capsules
Addl. Lower stgth
6. Diclofenac + Thiocolchicoside 21-10-2008
50mg EC + 8mg capsules
For the treatment of acute inflammatory conditions associated
with spasms in adults only
7. Diclofenac 50mg + 16-03-2010
Chlorzoxazone 500mg tablets
For the treatment of acute inflammatory conditions associated
with spasms only
8.Diclofenac 50mg + 24-01-2008
Serratiopeptidase 10mg EC tablets
For the treatment of acute pain in adults
9. Diclofenac Colestyramine 145.6mg 19-05-2011
Corresponding to 75mg Diclofenac
Sodium capsules
For the treatment of acute arthiriris (including attacks of Gout),
chronic arthiitis especially Rheumatoid arthiritis ( chronic
polyarthiritis) ankylosing spondylosis ( Morbus Bechterew)
and other inflammatory , Rheumatoid syndromes of vertebral
column
10.Diclofenac Diethylamine BP 2.32% 01-01-2013
w/w eq. to diclofenac sodium 2%w/v+
Methyl salicylate IP 10% w/v +
Menthol IP 10% v/v topical solution
(Addl. stgth.)
For the treatment of acute lower back pain
11.Diclofenac diethylamine transdermal 04-12-2009
patch 100mg/37.5 sq.cm ( Addl.Stgth.)
Same as approved
12. Diclofenac Potassium 50mg + 08-04-2008
Serriatopeptidase (as EC pellets)
15mg Capsules
( Addl.Stgth.)
For the treatment of acute pain in adults
13.Diclofenac Sodium 75/50mg) as EC 28-02-2006
+ Misoprostol 200mcg
For OA & RA
14. Diclofenac Sodium SR 100mg+ 24-08-2011
Esperisone Hcl SR 150mg capsules
For the treatment of patient with acute musculoskeletal spasm
associated with low back pain
15. Diclofenac Sodium 75mg/ml 30-07-2007
injection ( Addl.Stgth.)
For the management of painful conditions in post-operative cases,
rheumatoid arthiritis and osteoarthiritis
16.Diclofenac Sodium 100mg SR pellets + 31-01-2008
Rabeprazole Sodium 20mg EC pellets
Capsules
For the treatment of painful inflammatory conditions associated
with Gastroduodenal ulcers
17.Diclofenac Sodium 50mg + 02-06-2008
Codeine Phosphate 50mg tablets
For the treatment of adult patients with signs and symptoms of
acute painful conditions
18. Diclofenac Sodium 50mg + 28-01-2008
Dicyclomine Hcl 20mg/ml of Injection
For the treatment of acute colicky pain in adults
19. Diclofenac Sodium 50mg + 30-01-2008
Paracetamol 500mg tablets
For the symptomatic treatment of acute pain and inflammation in
patients with osteoarthiritis, rheumatoid arthiritis and ankylosing
spondylitis
20. Diclofenac Sodium SR (two layered 20-12-2013
tablet) 150mg . Each tablet contains
Diclofenac Sodium IP 125mg Slow release
Diclofenac IP 25mg - Immediate release
( Addl.dosage Form)
For symptomatic treatment of pain and inflammation in irritation in
association with degenertive joint diasease / osteoarthiritis
21. Diclofenac Sodium SR tablet 150mg 26-03-2010
For the treatment of rheumatoid arthiritis, osteoarthiritis, ankylosing
spondilytis, Gout, Painful post operative pain, following Dental
surgery etc.
22. Diclofenac transdermal patch 6-10-2004
200mg/75 cm2
For pain relief
23. Diclofenac Sodium IP ( as SR pellets) 15-11-2011
100mg + Thiocolchicoside ( as SR pellets)
16mg capsule
( New Dosage Form)
For the treatment of acute inflammation conditions associated with
spasm in adult only
24. Diclofenac Sodium IP (ER granules) 06-01-2012
50mg + Eperisone HCl IP (tablet) 50mg
Hard gelatin capsules
( New Dosage Form)
For the treatment of patients with acute musculoskeletal spasm associated
with low back pain
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Diclofenac 100mg EC+ 06-07-2010
Thiocolchicoside 8mg capsule
For secondary prophylaxis of ischemic herat disease in patients
where use of such combinations is appropiate
2. Diclofenac 50mg + 24-01-2008
Serratiopeptidase 10mg enteric coated tablets
For the treatment of acute pain in adults
3. Diclofenac Diethylamine 1.16% w/w eq. to 09-06-2008
Diclofenac Sodium 1%w/w+
Methyl Salicylate , Linseed Oil, Menthol)
For the treatment of acute painful condition
(Swelling and inflamation) due to musculoskeletal
disorder
4.Diclofenac Diethylamine BP 2.32 % eq. to 01-01-2013
Diclofenac Sodium 2.0% w/v +
Methyl salicylate IP 10.0% +
Menthol 5.0% w/v +
Absolute Alcohlol IP 10.0% v/v Topical Solution
(Addl.Sgth.)
For the treatment of Lower back Pain
5.Diclofenc Potassium 50mg + 08-04-2008
Serratiopeptidase (as enteric coated pellets)
15mg capsules
Addl.stgth
For the treatment of acute pain in adults
6. Doclofenac Sodium 1mg + 26-03-1999
Gentamycin Sodium 3mg/ml
Inflammation of the interior segmant of the eye where
there is a risk of bactrial occular infection
Indication
Rheumatoid arthritis
NSAIDs include-
Propionic acid- Fenoprofen, Flurbiprofen, Ibuprofen, Ketoprofen, Naproxen, Naproxen Sodium, Oxaprozin
Acetic acids- Diclofenac sodium, Etodolac, Indomethicin, Ketorolac, Nabumetone, Sulindac, Tolmetin
Fenamates (anthralic acids) - Meclofenamate, Mefenamic acxid
Oxicams- Piroxicam
Refer- Ibuprofen