| View |
|
DR-XY48775
|
Ciprofloxacin (as hydrochloride)
|
Ciprobay
|
500 mg
|
Film-Coated Tablet
|
-
|
Bayer Healthcare Manufacturing S.R.L
|
Italy
|
Initial (Reapplication) (Correction)
|
17 October 2023
|
20 June 2028
|
| View |
|
DRP-14124
|
Metformin hydrochloride
|
Diabemin XR
|
750 mg
|
Extended-Release Tablet
|
Blood Glucose-Lowering Drug (Biguanide)
|
PT Ferron Par Pharmaceuticals
|
Indonesia
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14085
|
Sitagliptin
|
Zincretin 50
|
50 mg
|
Film Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Zydus Lifesciences Limited
|
India
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14103
|
Pantoprazole (As Sodium)
|
Vanprozal
|
40mg
|
Lyophilized Powder for Intravenous Injection
|
Proton Pump Inhibitor
|
Pharmax India Private Limited
|
India
|
Initial
|
21 June 2023
|
21 June 2028
|
| View |
|
DR-XY48776
|
Montelukast (as sodium) + Levocetirizine hydrochloride
|
None
|
5mg/5mg
|
Chewable Tablet
|
Leukotriene Receptor Antagonist-Antihistamine Combination
|
Ajanta Pharma Limited
|
India
|
Initial
|
18 July 2023
|
18 July 2028
|
| View |
|
DRP-14102
|
Ceftriaxone (As Sodium)
|
Ceftron
|
1 g
|
Powder For Injection (IM/IV)
|
Antibacterial (Third-generation Cephalosporin)
|
Reyoung Pharmaceutical Co., Ltd
|
China
|
Initial
|
21 June 2023
|
21 June 2028
|
| View |
|
DR-XY48777
|
Montelukast (as sodium) + Levocetirizine
hydrochloride
|
None
|
5 mg/2.5 mg
|
Chewable Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
22 June 2023
|
22 June 2028
|
| View |
|
DRP-14126
|
Glimepiride
|
Limglim
|
2 mg
|
Film-Coated Tablet
|
Blood Glucose-Lowering Drug (Sulfonylurea)
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14125
|
Glibenclamide
|
Dialin
|
5 mg
|
Tablet
|
Blood Glucose-Lowering Drug (Sulfonylurea)
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial (Correction)
|
03 October 2023
|
23 June 2028
|
| View |
|
DRP-14127
|
Olanzapine
|
Joyola
|
10 mg
|
Film-Coated Tablet
|
Antipsychotic
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DR-XY 48778
|
Omeprazole (as sodium monohydrate).
|
Fluxzol
|
40 mg
|
Lyophilized Powder for Intravenous Injection
|
Proton Pump Inhibitor
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
22 June 2023
|
22 June 2028
|
| View |
|
DRP-14100
|
Budesonide
|
None
|
200 mcg
|
Dry Powder in Inhalation in Capsule
|
Corticosteroid (Glucocorticoid)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
21 June 2023
|
21 June 2028
|
| View |
|
DRP-14084
|
Sitagliptin
|
Zita 50
|
50 mg
|
Film Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Zydus Lifesciences Limited.
|
India
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14083
|
Sitagliptin
|
Zita 100
|
100 mg
|
Film Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Zydus Lifesciences Limited
|
India
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14099
|
Vancomycin (as hydrochloride)
|
Vankar 500
|
500 mg
|
Lyophilized Powder For Injection (I.V.) Infusion
|
-
|
Sakar Healthcare Limited
|
India
|
Initial
|
21 June 2023
|
21 June 2028
|
| View |
|
DRP-14120
|
Cefixime (as trihydrate)
|
Cefitome
|
200 mg
|
Film Coated Tablet
|
Antibacterial (Cephalosporin)
|
Indchemie Health Specialties Private Limited
|
India
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14110
|
Capecitabine
|
CAPTP 500
|
500mg
|
Film-coated Tablet
|
Antimetabolite (Pyrimidine analogue)
|
Globela Pharma Private Limited
|
India
|
Initial
|
22 June 2023
|
22 June 2028
|
| View |
|
DRP-14111
|
Valacyclovir (As Hydrochloride)
|
Herpival-500
|
500mg
|
Film coated Tablet
|
Antiviral
|
KLM Laboratories Pvt. Ltd.
|
India
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14112
|
Etoricoxib
|
Vcoxib 90
|
90 mg
|
Film-coated Tablets
|
Non-steroidal Anti-inflammatory and Antirheumatic
|
Globela Pharma Private Limited
|
India
|
Initial
|
22 June 2023
|
22 June 2028
|
| View |
|
DR-XY48784
|
Cilostazol
|
Cilosol 100
|
100 mg
|
Tablet
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
23 June 2023
|
23 June 2028
|