| View |
|
DRP-14304
|
Telmisartan
|
Maxitel
|
40 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
16 August 2023
|
16 August 2028
|
| View |
|
DR-XY48841
|
Rizatriptan (as Benzoate)
|
Migratan
|
10 mg
|
Tablet
|
-
|
Zydus Lifesciences Limited
|
India
|
Monitored Release
|
09 August 2023
|
09 August 2028
|
| View |
|
DRP-14298
|
Haloperidol
|
Hapedrol
|
5 mg/mL
|
Solution for Injection (I.M.)
|
-
|
Indoco Remedies Limited
|
India
|
Initial
|
11 August 2023
|
11 August 2028
|
| View |
|
DRP-14277
|
Rosuvastatin (as Calcium)
|
Rosva 10
|
10mg
|
Film-Coated Tablet
|
-
|
Inventia Healthcare Limited
|
India
|
Initial
|
09 August 2023
|
09 August 2028
|
| View |
|
DRP-14276
|
Rosuvastatin (as Calcium)
|
Rosva 20
|
20 mg
|
Film-Coated Tablets
|
-
|
Inventia Healthcare Limited
|
India
|
Initial
|
09 August 2023
|
09 August 2028
|
| View |
|
BR-1448
|
Rotavirus Vaccine (Live, Attenuated)
|
Rotarix
|
NLT 106.0 CCID50/1.5 mL
|
Oral Suspension
|
-
|
GlaxoSmithKline Biologicals SA (GSK Biolpgicals)
|
Belgium
|
Initial
|
18 August 2023
|
18 August 2028
|
| View |
|
DRP-14274
|
Sitagliptin (as phosphate monohydrate)
+ Metformin Hydrochloride
|
Sitag-M 1000
|
50 mg/1000
|
Film-Coated Tablet
|
-
|
Bafna Pharmaceuticals Limited.
|
India
|
Initial
|
09 August 2023
|
09 August 2025
|
| View |
|
DR-XY48848
|
Trimetazidine Hydrochloride
|
Angimed
|
35 mg
|
Modified Release Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (Correction)
|
23 January 2024
|
16 August 2028
|
| View |
|
DRP-14278
|
Montelukast (as sodium)+Levocetirizine dihydrochloride
|
Montelev
|
10mg/5mg
|
Film-Coated Tablet
|
-
|
MAGBRO HEALTHCARE PVT. LTD.
|
India
|
Initial
|
09 August 2023
|
09 August 2028
|
| View |
|
DRP-14300
|
Doxofylline
|
Doxofyr
|
400 mg
|
Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial (Re-application)
|
14 August 2023
|
14 August 2028
|
| View |
|
DRP-14288
|
Celecoxib
|
Celdol 200
|
200 mg
|
Capsule
|
-
|
Aurobindo Pharma Limited (Unit VII)
|
India
|
Initial (Re-application)
|
10 August 2023
|
10 August 2028
|
| View |
|
DRP-14289
|
Celecoxib
|
None
|
200 mg
|
Capsule
|
-
|
Aurobindo Pharma Limited (Unit VII)
|
India
|
Initial (Re-application)
|
10 August 2023
|
10 August 2028
|
| View |
|
DRP-14273
|
Rosuvastatin (as Calcium)
|
Rosva 40
|
40 mg
|
Film-Coated Tablets
|
-
|
Inventia Healthcare Limited
|
India
|
Initial
|
09 August 2023
|
09 August 2028
|
| View |
|
DR-XY48839
|
Metformin Hydrochloride + Sitagliptin (as phosphate
monohydrate)
|
Sitaplus
|
1 g/50 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
10 August 2023
|
10 August 2028
|
| View |
|
DR-XY48840
|
Metformin Hydrochloride + Sitagliptin (as phosphate
monohydrate)
|
Sitaplus
|
500 mg/50 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
10 August 2023
|
10 August 2028
|
| View |
|
DR-XY48846
|
Telmisartan
|
Telsartin 40
|
40 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
14 August 2023
|
14 August 2028
|
| View |
|
DRP-14322
|
Tacrolimus
|
Tacrosin 0.03
|
300 mcg/g (0.03%w/w)
|
Topical Ointment
|
-
|
The Madras Pharmaceuticals
|
India
|
Initial
|
17 August 2023
|
17 August 2028
|
| View |
|
DRP-14323
|
Tacrolimus
|
Tacrosin 0.1
|
1 mg/g (0.1%w/w)
|
Topical Ointment
|
-
|
The Madras Pharmaceuticals
|
India
|
Initial
|
17 August 2023
|
17 August 2028
|
| View |
|
DR-XY48847
|
Telmisartan + Amlodipine (As Besilate)
|
Telmipin
|
40 mg/5 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
14 August 2023
|
14 August 2028
|
| View |
|
DR-XY48843
|
Telmisartan
|
Telsartin 80
|
80 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
10 August 2023
|
10 August 2028
|