View |
|
DRP-14175
|
Lidocaine Hydrochloride + Epinephrine
|
Lignosaph-Plus
|
20mg/10mcg per mL
|
Solution For Injection
|
-
|
Althea Pharma Pvt. Ltd.
|
India
|
Initial
|
14 July 2023
|
14 July 2028
|
View |
|
DRP-14628
|
Zinc Oxide + Calamine
|
Clazine
|
206 mg (20.6% w/w)/8 mg per gram (8% w/w)
|
Ointment
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
06 November 2023
|
06 November 2028
|
View |
|
DR-XY48814
|
Vildagliptin
|
Vigliptic-50
|
50 mg
|
Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Next Wave (India)
|
India
|
Initial
|
17 July 2023
|
17 July 2028
|
View |
DR-XY48932_PI_01.pdf
|
DR-XY48932
|
Cariprazine (as hydrochloride)
|
Reagila
|
6 mg
|
Capsule
|
-
|
Chemical Works of Gedeon Richter Plc.
|
Hungary
|
Monitored Release
|
24 November 2023
|
24 November 2028
|
View |
|
DRP-14194
|
Tranexamic Acid
|
Raxami
|
100 mg/Ml
|
Solution For Injection
|
-
|
SANJAR PHARMA LLP
|
India
|
Initial
|
17 July 2023
|
17 July 2028
|
View |
DR-XY48935_PI_01.pdf
|
DR-XY48935
|
Cariprazine (as hydrochloride)
|
Reagila
|
1.5 mg
|
Capsule
|
-
|
Chemical Works of Gedeon Richter
|
Hungary
|
Monitored Release
|
24 November 2023
|
24 November 2028
|
View |
DR-XY48934_PI_01.pdf
|
DR-XY48934
|
Cariprazine (as hydrochloride)
|
Reagila
|
3 mg
|
Capsule
|
-
|
Chemical Works of Gedeon Richter
|
Hungary
|
Monitored Release
|
24 November 2023
|
24 November 2028
|
View |
DR-XY48933_PI_01.pdf
|
DR-XY48933
|
Cariprazine (as hydrochloride)
|
Reagila
|
4.5 mg
|
Capsule
|
-
|
Chemical Works of Gedeon Richter
|
Hungary
|
Monitored Release
|
24 November 2023
|
24 November 2028
|
View |
|
DR-XY48925
|
Ascorbic Acid + Zinc+ Cholecalciferol (Vitamiu D3)
|
Pure-Cee' ZD
|
500 mg (equivalent to 562.50 mg Sodium Ascorbate)/
15 mg
(equivalent to 41.18 mg
Monohydrate)/1000 IU
|
Capsule
|
-
|
Growrich Manufacturing Inc.
|
Philippines
|
Initial
|
17 November 2023
|
17 November 2028
|
View |
|
DR-XY48924
|
Iron Zinc+ Folic acid
|
Feona FZ
|
48 mg (eq. to 350.784 mg Ferrous Ascorbate)/22.5 mg (eg. t (eq. to 61.80 mg Zinc Sulfate Monohydrate)/500 mcg
|
Film-Coated Tablet
|
-
|
Delta Pharma Ltd.
|
Bangladesh
|
Initial
|
17 November 2023
|
17 November 2028
|
View |
|
DRP-14636
|
Solifenacin succinate
|
Goab 5
|
5 mg
|
Film-Coated Tablet
|
-
|
Annora Pharma Private Limited
|
India
|
Initial
|
10 November 2023
|
10 November 2028
|
View |
DR-XY48815_PI_01.pdf
|
DR-XY48815
|
Irbesartan
|
Bezartan
|
300mg
|
Film-Coated Tablet
|
-
|
Duopharma Manufacturing (Bangi) Sdn. Bhd.
|
Malaysia
|
Initial (Re-application)
|
18 July 2023
|
18 July 2028
|
View |
|
BR-1454
|
Clostridium botulinum Toxin Type A
|
Botitox Up
|
100 Units
|
Lyophilized Powder for Solution for Injection
(IM)
|
-
|
Huons Biopharma Co., Ltd.
|
Korea
|
Initial (Reapplication)
|
07 November 2023
|
07 November 2028
|
View |
|
DRP-14633
|
Donepezil hydrochloride
|
Doneprizil
|
10 mg
|
Orally Disintegrating Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
08 November 2023
|
08 November 2028
|
View |
|
DR-XY48811
|
Rivaroxaban
|
Xaroban
|
20 mg
|
Film-Coated Tablet
|
-
|
The Searle Company Limited
|
Pakistan
|
Initial
|
14 July 2023
|
14 July 2028
|
View |
|
DRHR-2313
|
Mucopolysaccharide polysulfate
|
None
|
25,000 Units/100 g
|
Cream
|
-
|
Olic (Thailand) Limited
|
Thailand
|
Initial [OTC]
|
17 November 2023
|
17 November 2028
|
View |
|
DRP-14166
|
Solifenacin succinate
|
Vesizen 10
|
10 mg
|
Film-Coated Tablet
|
Drugs for Urinary Frequency and Incontinence
|
Sun Pharma Laboratories Ltd.
|
India
|
Initial (Correction)
|
26 September 2024
|
07 July 2028
|
View |
|
DRHR-2267
|
Camphor + Menthol
|
Superscent Relaxing Oil Classic Menthol
|
500mg/500mg per 10 ML
|
Liniment
|
-
|
Telstar Manufacturing Corporation
|
Philippines
|
Initial
|
19 July 2023
|
19 July 2028
|
View |
|
DRP-46035
|
Levetiracetam
|
None
|
100 mg/mL
|
Concentrate For Solution For Iv Infusion
|
-
|
Gland Pharma Limited
|
India
|
Initial (from Monitored Release)
|
27 July 2023
|
02 October 2027
|
View |
|
DRHR-2268
|
Ethyl Alcohol
|
Alcoshield Ethyl Alcohol 70% Solution (Armour Boost)
|
70% v/v
|
Solution
|
-
|
Nue Ark Philippines Inc.
|
Philippines
|
Initial
|
25 July 2023
|
25 July 2028
|