| View |
|
DRP-13968
|
Doxofylline
|
Maxivent
|
200mg
|
Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
29 May 2023
|
28 December 2027
|
| View |
|
DRP-13156
|
Pioglitazone (as Hydrochloride)
|
Pioglinova-15
|
15 mg
|
Tablet
|
-
|
Ind-Swift Limited
|
India
|
Initial
|
12 December 2022
|
12 December 2027
|
| View |
|
DRP-13174
|
Quetiapine (As Fumarate)
|
Quitide 200
|
200 mg
|
Film-Coated Tablet
|
-
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
14 December 2022
|
14 December 2025
|
| View |
|
DRP-13173
|
Quetiapine (As Fumarate)
|
Quitide 100
|
100 mg
|
Film-Coated Tablet
|
-
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
14 December 2022
|
14 December 2025
|
| View |
|
DRP-13175
|
Quetiapine (As Fumarate)
|
Quitide 300
|
300 mg
|
Film-Coated Tablet
|
-
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
14 December 2022
|
14 December 2025
|
| View |
|
DRP-13172
|
Quetiapine (As Fumarate)
|
Quitide 25
|
25 mg
|
Film-Coated Tablet
|
-
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
14 December 2022
|
14 December 2025
|
| View |
|
DRP-13200
|
Prednisolone (As Sodium Phosphate)
|
Saphnisolone-15
|
15mg/5mL
|
Syrup (Grapes Flavor) :
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
28 December 2022
|
28 December 2027
|
| View |
|
DRP-13201
|
Prednisolone (As Sodium Phosphate)
|
Saphsolone-15
|
15mg/5mL
|
Syrup (Grapes Flavor) :
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
28 December 2022
|
28 December 2027
|
| View |
|
DRP-13131
|
Tacrolimus
|
Tacrohab
|
300 mcg/g (0.03% w/w)
|
Topical Ointment
|
-
|
Genuone Sciences Inc.
|
Korea
|
Initial (Rx)
|
06 December 2022
|
06 December 2027
|
| View |
|
DRP-13158
|
Fulvestrant
|
Fulvetrant
|
50 mg/mL (250mg/5mL)
|
Solution For Injection (IM)
|
Anti-estrogen
|
Sun Pharmaceutical Industries Ltd
|
India
|
Initial (Reconstruction)
|
31 July 2024
|
12 December 2027
|
| View |
DR-XY48546_PI_01.pdf
|
DR-XY48546
|
Sitagliptin (As Hydrochloride)
|
Sitazit 100
|
100 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited, Unit V
|
India
|
Monitored Release
|
29 December 2022
|
29 December 2027
|
| View |
DR-XY48548_PI_01.pdf
|
DR-XY48548
|
Sitagliptin (As Hydrochloride)
|
Sitazit 50
|
50 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited, Unit V
|
India
|
Monitored Release
|
29 December 2022
|
29 December 2027
|
| View |
DR-XY48547_PI_01.pdf
|
DR-XY48547
|
Sitagliptin (As Hydrochloride)
|
Sitazit 25
|
25 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited, Unit V
|
India
|
Monitored Release
|
29 December 2022
|
29 December 2027
|
| View |
|
DR-XY48521
|
Clopidogrel (As Bisulfate) + Rosuvastatin (as Calcium)
|
None
|
75mg/10mg
|
Capsule
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
06 December 2022
|
06 December 2027
|
| View |
|
DR-XY48520
|
Clopidogrel (As Bisulfate) + Rosuvastatin (As Calcium)
|
None
|
75mg/20mg
|
Capsule
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
06 December 2022
|
06 December 2027
|
| View |
|
DR-XY48538
|
Montelukast (as sodium) + Levocetirizine hydrochloride
|
None
|
10 mg/ 5 mg
|
Film Coated Tablet
|
-
|
Cadila Healthcare Limited
|
India
|
Initial
|
23 December 2022
|
23 December 2027
|
| View |
|
DR-XY48550
|
Risperidone
|
Rosemide
|
4 mg
|
Orodispersible Tablet
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Monitored Release
|
29 December 2022
|
29 December 2027
|
| View |
|
DR-XY48532
|
Fentanyl (as citrate)
|
Fentamar
|
50 mcg/mL (100 mcg/2 mL)
|
Solution For Injection (I.M./I.V.)
|
-
|
HBM Pharma S.R.O.
|
Slovak Republic
|
Initial [Correction]
|
02 March 2023
|
16 December 2027
|
| View |
DRP-5447-01_PI_01.pdf
|
DRP-5447-01
|
Cotrimozaxole (Butterscotch Flavor)
|
Moxatrim
|
200 mg/40 mg per 5 mL
|
Suspension
|
Antibacterial (Sulfonamide)
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Renewal
|
25 July 2024
|
17 December 2029
|
| View |
|
DR-XY47309
|
Carbocisteine + Zinc
|
Solmux Advance
|
500 mg/ 10 per 5 mL
|
Suspension (Soothing Mint Flavor)
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial
|
22 June 2021
|
22 June 2026
|