| View |
|
DR-XY47977
|
Empagliflozin + Metformin Hydrochloride
|
Jardiance Duo
|
5mg/850mg
|
Film-Coated Tablet
|
-
|
Boehringer Ingelheim Ellas A.E
|
Greece
|
-
|
29 April 2022
|
29 April 2027
|
| View |
|
DR-XY47976
|
Empagliflozin + Metformin Hydrochloride
|
Jardiance Duo
|
5mg/1g
|
Film-Coated Tablet
|
-
|
Boehringer Ingelheim Ellas A.E
|
Greece
|
-
|
29 April 2022
|
29 April 2027
|
| View |
|
DRP-11745
|
Cisplatin
|
Platihex
|
1 mg/mL (50 mg/50 mL)
|
Concentrate for Solution for
Infusion (IV)
|
Antineoplastic agents
|
SP Accure Labs Pvt. Ltd.
|
India
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
|
DRP-11765
|
Clindamycin (as hydrochloride)
|
None
|
300 mg
|
Capsule
|
Antibacterial (Lincosamide)
|
AM-EUROPHARMA CORPORATION
|
Philippines
|
Initial
|
29 April 2022
|
29 April 2027
|
| View |
DRP-11766_PI_01.pdf
|
DRP-11766
|
Diltiazem Hydrochloride
|
Novoptin
|
30mg
|
Tablet
|
-
|
San Marino Laboratories Corporation
|
Philippines
|
-
|
29 April 2022
|
29 April 2025
|
| View |
|
DRP-11739
|
Ceftazidime (As Pentahydrate)
|
Halcef
|
1 g
|
Powder For Injection (IM/IV)
|
Antibacterial (Cephalosporin)
|
Medisure Laboratories Pakistan Pvt Ltd
|
Pakistan
|
Initial
|
22 April 2022
|
22 April 2027
|
| View |
DR-XY47930_PI_01.pdf
|
DR-XY47930
|
Linagliptin + Metformin Hyydrochloride
|
Trajenta Duo
|
2.5mg/850mg
|
Film-Coated Tablet
|
Oral Blood Glucose Lowering Drug Combination
|
Boehringer Ingelheim Promeco, S.A. de C.V.
|
Mexico
|
Initial
|
12 April 2022
|
12 April 2027
|
| View |
|
DR-XY 47929
|
Linagliptin + Metformin Hyydrochloride
|
Trajenta Duo
|
2.5mg/1g
|
Film-Coated Tablet
|
Oral Blood Glucose Lowering Drug Combination
|
Boehringer Ingelheim Promeco, S.A. de C.V.
|
Mexico
|
Initial
|
12 April 2022
|
12 April 2027
|
| View |
|
DRP-11799
|
Piracetam
|
Nootrotam
|
200 mg/mL (1 g/5 mL)
|
Solution for Infusion (I.M./I.V.)
|
Nootropic
|
Osel Ilaç San. Ve Tic A.Ş.
|
Turkey
|
Initial
|
29 April 2022
|
29 April 2027
|
| View |
|
DR-XY47960
|
Levonorgestrel + Ethinylestradiol
|
Conchoice
|
150 mcg/30 mcg
|
Tablet
|
Hormonal Contraceptive
|
Sun Pharmaceutical Industries Ltd.
|
India
|
Initial
|
27 April 2022
|
27 April 2027
|
| View |
|
BRP-041-05
|
Enoxaparin Sodium
|
Vintrenox
|
4000 IU anti-Factor Xa (equivalent to 40 mg) / 0.4 mL
|
Solution for Injection (SC)
|
Anticoagulant
|
Brawn Laboratories Ltd.
|
India
|
Initial (Revalidation)
|
25 April 2022
|
09 December 2025
|
| View |
|
BRP-041-17
|
Enoxaparin sodium
|
Enoxfadz 4000
|
4000 IU Anti-Factor Xa (Equivalent to 40 mg) / 0.4 mL
|
Solution for Injection (SC)
|
Anticoagulant
|
Brawn Laboratories Ltd.
|
India
|
Initial (Revalidation)
|
27 April 2022
|
09 December 2025
|
| View |
|
DRP-11793
|
Ketoconazole
|
Ketsokant
|
20 mg/g (2% w/w)
|
Cream
|
-
|
S Kant Healthcare Limited
|
India
|
-
|
29 April 2022
|
29 April 2027
|
| View |
|
DRP-11818
|
Carbocisteine
|
Mucofar
|
500 mg
|
Capsule
|
Mucolytic
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
04 May 2022
|
04 May 2027
|
| View |
|
DRP-11819
|
Hyoscine-N-Butylbromide
|
Hyopan
|
10 mg
|
Sugar-Coated Tablet
|
Antispasmodic
|
Fredun Pharmaceuitcals, Ltd.
|
India
|
Initial (OTC](Correction)
|
16 May 2022
|
04 May 2027
|
| View |
|
DRP-11820
|
Ascorbic Acid
|
None
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate)
|
Capsule
|
Vitamin
|
Ashford Pharmaceuticals Laboratories, Inc.
|
Philippines
|
Initial
|
04 May 2022
|
04 May 2027
|
| View |
|
DRP-11812
|
Ascorbic Acid + Zinc
|
Revitacee
|
500 mg (equivalent to 562.54 mg Sodium Ascorbate) /
10 mg (equivalent to 27.5 mg Zinc Sulfate)
|
Caplet
|
Vitamin & Mineral
|
Pharmatechnica Laboratory Inc.
|
Philippines
|
Initial [OTC] (Reconstruction)
|
16 January 2024
|
02 May 2027
|
| View |
|
DRP-11836
|
Methotrexate
|
Trexasaph
|
100 mg/mL
|
Solution For Injection (IM/IV)
|
Antineoplastic Agent (Folic Acid Analogue)
|
Bruck Pharma Private Limited
|
India
|
Initial
|
05 May 2022
|
05 May 2027
|
| View |
|
DRP-11810
|
Ascorbic Acid + Zinc
|
None
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate)/
10 mg (equivalent to 27.45 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Vitamin & Mineral
|
Phil. United Pharma Corporation
|
Philippines
|
Initial (OTC)
|
02 May 2022
|
02 May 2027
|
| View |
|
DRP-11811
|
Ascorbic Acid + Zinc
|
First C + Z
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate) /
10 mg (equivalent to 27.5 mg Zinc Sulfate)
|
Capsule
|
Vitamin & Mineral
|
Pharmatechnica Laboratory Inc.
|
Philippines
|
Initial [OTC]
|
02 May 2022
|
02 May 2027
|