View |
|
DRP-14243
|
Iohexol
|
Contrahex
|
755 mg/mL (equivalent to 350 mg Iodine)
|
Solution for
Intravascular Injection
|
-
|
Cisen Pharmaceutical Co., Ltd.
|
China
|
Initial
|
02 August 2023
|
02 August 2028
|
View |
|
DRP-14244
|
Iohexol
|
Contrahex
|
647 mg/mL (equivalent to 300 mg Iodine)
|
Solution for
Intrathecal Injection
|
-
|
Cisen Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
22 November 2023
|
02 August 2028
|
View |
|
DR-XY48831
|
Clotimazole
|
Candigo
|
10mg/g (1% w/w)
|
Cream
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial (Correction)
|
01 August 2023
|
06 June 2028
|
View |
|
DRP-14258
|
Caspofungin (as acetate)
|
Brufungin 50
|
50 mg
|
Lyophilized Powder for IV Infusion
|
-
|
Brawn Laboratories Ltd.
|
India
|
Initial
|
07 August 2023
|
07 August 2028
|
View |
|
DRP-14236
|
Telmisartan + Hydrochlorothiazide
|
Tsartan Plus
|
80mg/12.5mg
|
Tablet
|
-
|
Inventia Healthcare Limited
|
India
|
Initial
|
01 August 2023
|
01 August 2028
|
View |
|
DRP-14257
|
Clindamycin (as hydrochloride)
|
None
|
300 mg
|
Capsule
|
-
|
UNITED BIOTECH (P) LIMITED
|
India
|
Initial
|
07 August 2023
|
07 August 2028
|
View |
|
DR-XY48832
|
Amlodipine (as Besilate + Olmesartan Medoxomil
|
Olmesar-Am 5/20
|
5 mg/20 mg
|
Tablet
|
-
|
Hetero Labs Limited (Unit V)
|
India
|
Initial
|
01 August 2023
|
01 August 2028
|
View |
|
DR-XY4883
|
Amlodipine (as Besilate) + Olmesartan Medoxomil
|
Olmesar-Am 5/40
|
5 mg/40 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit V)
|
India
|
Initial
|
01 August 2023
|
01 August 2028
|
View |
|
DRP-14216
|
Dutasteride
|
Armadart
|
500 mcg
|
Softgel Capsule
|
-
|
Yuyu Pharma Inc.
|
Korea
|
Initial
|
31 July 2023
|
31 July 2028
|
View |
|
DR-XY48836
|
Meropenem (as trihydrate)
|
Meronash 1000
|
1g
|
Powder For Injection (Iv)
|
-
|
Shamshree Lifesciences Ltd.
|
India
|
Initial
|
03 August 2023
|
03 August 2028
|
View |
|
HMR-177
|
Vitex Negundo L. Lagundi Leaf
|
Lagundex Forte
|
600 mg/5 mL
|
Syrup (Peppermint Flavor)
|
-
|
La Croesus Pharma, Inc.
|
Philippines
|
Initial
|
02 August 2023
|
02 August 2028
|
View |
|
DRP-14259
|
Co-Amoxiclav
|
None
|
375mg
|
Film-Coated Tablet
|
-
|
Sunlovis Pharmaceuticals LLP.
|
India
|
Initial
|
07 August 2023
|
07 August 2028
|
View |
|
DRP-14195
|
Co-Amoxiclav
|
None
|
1g
|
Film-Coated Tablet
|
-
|
Bueno Salud Care (India) Pvt. Ltd.
|
India
|
Initial
|
07 August 2023
|
07 August 2028
|
View |
|
DRP-14260
|
Co-Amoxiclav
|
Co-Amoxisaph 375
|
375mg
|
Film-Coated Tablet
|
-
|
Bueno Salud Care (India) Pvt. Ltd.
|
India
|
Initial
|
07 August 2023
|
07 August 2028
|
View |
|
DR-XY48824
|
Paracetamol + Guaifenesin + Phenylpropanolamine
(as hydrochloride) + Dextromethorphan hydrobromide + Chlorpheniramine maleate
|
Dexofen
|
325 mg/50 mg/10 mg/10 mg/2 mg
|
Capsule
|
-
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Initial
|
31 July 2023
|
31 July 2028
|
View |
|
DRP-14256
|
Metformin Hydrochloride
|
Formigen 500
|
500mg
|
Film-Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
04 August 2023
|
04 August 2025
|
View |
|
DRP-14254
|
Metformin Hydrochloride
|
Formigen 1000
|
1 g
|
Film-Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
04 August 2023
|
04 August 2025
|
View |
|
DRP-14255
|
Metformin Hydrochloride
|
Formigen 850
|
850mg
|
Film-Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
04 August 2023
|
04 August 2025
|
View |
|
DRP-14248
|
Pioglitazone (as hydrochloride)
|
Ziaton
|
15mg
|
TABLET
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
02 August 2023
|
02 August 2028
|
View |
|
DRP-14247
|
Metformin Hydrochloride
|
Etromin 500
|
500mg
|
Film-Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
02 August 2023
|
02 August 2025
|