| View |
|
DRP-12166-02
|
Pantoprazole (as sodium)
|
Goprax
|
40 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
Globela Pharma Private Limited
|
India
|
CLIDP Conversion
|
28 March 2024
|
23 June 2027
|
| View |
|
DRP-12190-02
|
Loperamide Hydrochloride
|
Lopedium
|
2 mg
|
Capsule
|
Antidiarrheal
|
Ratnatris Pharmaceuticals Private Limited
|
India
|
CLIDP Conversion
|
09 March 2024
|
28 June 2027
|
| View |
|
DRP-12192-02
|
Co-Amoxiclav
|
Clavomex
|
457 mg/5 mL
|
Powder for Oral Suspension
|
Antibacterial (Penicillin)s
|
J.M. Tolmann Laboratories, Inc
|
Philippines
|
CLIDP Conversion
|
28 March 2024
|
02 September 2027
|
| View |
|
DRP-12257-04
|
Fenofibrate
|
None
|
160 mg
|
Micronized Capsule
|
Lipid Modifying Agent (Fibrate)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
CLIDP Conversion
|
24 March 2024
|
05 July 2027
|
| View |
|
DRP-12263-03
|
Ursodeoxycholic Acid
|
Urlyx 500
|
500 mg
|
Film-Coated Tablet
|
Bile Acid and Derivative
|
Globela Pharma Private Limited
|
India
|
CLIDP Conversion
|
09 March 2024
|
06 July 2027
|
| View |
|
DRP-12312-01
|
Esomeprazole (as magnesium trihydrate)
|
None
|
40 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
CLIDP Conversion
|
26 March 2024
|
15 July 2027
|
| View |
|
DRP-12292-04
|
Febuxostat
|
Febutor-40
|
40 mg
|
Film-Coated Tablet
|
Antigout
|
Cooper Pharma Limited
|
India
|
CLIDP Conversion
|
08 March 2024
|
12 July 2027
|
| View |
|
DRP-12291-03
|
Febuxostat
|
Furinil
|
80 mg
|
Film-Coated Tablet
|
Antigout
|
Cooper Pharma Limited
|
India
|
CLIDP Conversion
|
09 March 2024
|
11 July 2027
|
| View |
|
DRP-15036
|
Gabapentin
|
Gapenak 400
|
400 mg
|
Capsule
|
Antiepileptic
|
Hetero Labs Limited (Unit V)
|
India
|
Initial
|
25 March 2024
|
25 March 2029
|
| View |
|
DRP-15037
|
Gabapentin
|
Gapenak 300
|
300 mg
|
Capsule
|
Antiepileptic
|
Hetero Labs Limited (Unit V)
|
India
|
Initial
|
25 March 2024
|
25 March 2029
|
| View |
|
DRP-15041
|
Gemcitabine Hydrochloride
|
Luocitabin
|
200 mg
|
Lyophilized Powder for IV Injection
|
Antineoplastic (Pyrimidine Analogue)
|
Shandong Luoxin Pharmaceutical Group Stock Co.,
Ltd.
|
China
|
Initial
|
27 February 2024
|
27 March 2029
|
| View |
|
DR-XY49029
|
Irinotecan hydrochloride (as trihydrate)
|
Insvex
|
20 mg/mL (40 mg/2 mL)
|
Concentrate Solution for IV Infusion
|
Antineoplastic Agent
|
Venus Remedies, Limited
|
India
|
Initial
|
27 March 2024
|
27 March 2029
|
| View |
|
DRP-15043
|
Irbesartan + Amlodipine (as Besilate)
|
Adisart
|
150 mg/5 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB)/Calcium
Channel Blocker
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
27 March 2024
|
27 March 2029
|
| View |
|
DRP-15042
|
Irbesartan + Amlodipine (as Besilate)
|
Adisart
|
300 mg/5mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB)/Calcium
Channel Blocker
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
27 March 2024
|
27 March 2029
|
| View |
|
DRP-15038
|
Losartan Potassium + Amlodipine (as besilate)
|
Cardivest Plus
|
50 mg/5 mg
|
Film-Coated Tablet
|
Angiotensin II receptor blocker (ARB) and calcium channel blocker
|
Magbro Healthcare Pvt. Ltd.
|
Philippines
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
|
DR-XY49027
|
Febuxostat
|
Febulas 40
|
40 mg
|
Film-Coated Tablet
|
Anti-gout (Preparation Inhibiting Uric Acid Production)
|
Delta Pharma Ltd.
|
Bangladesh
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
|
HRP-644
|
Oral Rehydration Salts
|
SRA-ORS Lychee
|
FORMULATION
Each sachet (4.1 g) contains:
Glucose Anhydrous
2.70 g
Trisodium Citrate Dihydrate 580 mg Sodium Chloride
520 mg
Potassium Chloride
300 mg
|
Granules for Oral Solution
(Lychee Flavor)
|
Electrolytes with Carbohydrates
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
|
HRP-645
|
Oral Rehydration Salts
|
SRA-ORS Melon
|
FORMULATION
Each sachet (4.1 g) contains:
Glucose Anhydrous
2.70 g
Trisodium Citrate Dihydrate 580 mg Sodium Chloride
520 mg
Potassium Chloride
300 mg
|
Granules for Oral Solution (Melon Flavor)
|
Electrolytes with Carbohydrates
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
|
HRP-646
|
Oral Rehydration Salts
|
SRA-ORS Strawberry
|
FORMULATION
Each sachet (4.1 g) contains:
Glucose Anhydrous
2.70 g
Trisodium Citrate Dihydrate 580 mg Sodium Chloride
520 mg
Potassium Chloride
300 mg
|
Granules for Oral Solution
(Strawberry Flavor)
|
Electrolytes with Carbohydrates
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
|
DR-XY49028
|
Rivaroxaban
|
Verxaban
|
20 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Direct factor Xa inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
26 March 2024
|
26 March 2029
|