| View |
|
DRP-13327
|
Amlodipine (As Besilate)
|
Amzur
|
10 mg
|
Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
27 January 2023
|
27 January 2028
|
| View |
|
DRP-13328
|
Gabapentin
|
Gabarx
|
100mg
|
Capsule
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
27 January 2023
|
27 January 2028
|
| View |
|
DRP-13353
|
Calcitriol
|
Cholergol
|
0.25 mcg
|
Softgel Capsule
|
-
|
Yuyu Pharma, Inc.
|
Korea
|
Initial
|
02 February 2023
|
02 February 2028
|
| View |
|
DRP-13348
|
Ketoconazole
|
Saphconazole
|
20 mg/g (2% w/w)
|
Cream
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
02 February 2023
|
02 February 2028
|
| View |
|
DR-XY48573
|
Mometasone Furoate
|
Melomet
|
1 mg/g (0.1% w/w)
|
Topical Cream
|
-
|
Y.S.P. Industries (M) SDN. BHD.
|
Malaysia
|
Initial (OTC)
|
26 January 2023
|
26 January 2028
|
| View |
|
DR-XY48598
|
Palbociclib
|
Palvored 75
|
75 mg
|
Capsule
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Monitored Release
|
02 February 2023
|
02 February 2026
|
| View |
|
DR-XY48597
|
Palbociclib
|
Palvored 100
|
100 mg
|
Capsule
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Monitored Release
|
02 February 2023
|
01 February 2026
|
| View |
|
DR-XY48593
|
Palbociclib
|
Palvored 125
|
125 mg
|
Capsule
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Monitored Release
|
01 February 2023
|
01 February 2026
|
| View |
|
DRP-13325
|
Ursodeoxycholic Acid
|
Ursov
|
250mg
|
Film-Coated Tablets
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
27 January 2023
|
27 January 2028
|
| View |
|
DRP-13352
|
Apixaban
|
None
|
2.5 mg
|
Film-Coated Tablet
|
-
|
Natco Pharma Limited (Unit IV and V)
|
India
|
Initial
|
02 February 2023
|
02 February 2028
|
| View |
|
DRP-13349
|
Meropenem (as Trihydrate)
|
Merrovid
|
1 g
|
Powder For Solution For Injection (IV)
|
-
|
Brooks Steriscience Limited
|
India
|
Initial
|
02 February 2023
|
02 February 2028
|
| View |
|
DRP-13320
|
Ofloxacin
|
Ofloxasaph-Ot
|
2 mg/mL (200 mg/100 mL)
|
Solution For I.V. Infusion
|
-
|
Althea Pharma Pvt. Ltd.
|
India
|
Initial
|
26 January 2023
|
26 January 2028
|
| View |
|
DRP-13283
|
Levetiracetam
|
Leveleptic
|
250 mg
|
Film-Coated Tablet
|
-
|
Bafna Pharmaceuticals Limited
|
India
|
Initial
|
02 February 2023
|
02 February 2028
|
| View |
|
DRP-13281
|
Levetiracetam
|
Leveleptic
|
500 mg
|
Film-Coated Tablet
|
-
|
Bafna Pharmaceuticals Limited
|
India
|
Initial
|
02 February 2023
|
02 February 2028
|
| View |
|
DR-XY48605
|
Apixaban
|
Torapix 5
|
5mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
03 February 2023
|
03 February 2028
|
| View |
|
DR-XY48606
|
Apixaban
|
Torapix 2.5
|
2.5mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
03 February 2023
|
03 February 2028
|
| View |
|
DRP-13311
|
Thiamine Mononitrate (Vitamin B1) + Pyridoxine Hydrochloride (Vitamin B6)+ Cyanocobalamin
(Vitamin B12)
|
Bmac
|
100 mg/200mg/ 200mcg
|
Tablet
|
-
|
Tulip Lab Private Limited
|
India
|
Initial (OTC)
|
02 February 2023
|
02 February 2028
|
| View |
|
DRP-13329
|
Bisoprolol Fumarate
|
None
|
5mg
|
Film-Coated Tablet
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
Initial
|
27 January 2023
|
27 January 2028
|
| View |
|
DRP-13330
|
Bisoprolol Fumarate
|
Bisobloc 5
|
5mg
|
Film-Coated Tablet
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
Initial
|
27 January 2023
|
27 January 2028
|
| View |
|
DRP-13331
|
Bisoprolol Fumarate
|
Docbeta
|
5 mg
|
Film-Coated Tablet
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
Initial
|
27 January 2023
|
27 January 2028
|