| View |
|
DRP-14939
|
Co-Amoxiclav
|
Orancla 625
|
625 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin/Beta-Lactamase Inhibitor)
|
Indchemie Health Specialties Private Limited
|
India
|
Initial
|
21 February 2024
|
21 February 2029
|
| View |
|
DR-XY49004
|
Carboprost (as tromethamine)
|
Myoprost
|
250 mcg/mL
|
Solution for Injection (I.M)
|
Uterotonic (Prostaglandin)
|
Ciron Drugs & Pharmaceuticals Pvt. Limited
|
India
|
Initial (Reapplication)
|
21 February 2024
|
21 February 2029
|
| View |
|
DR-XY49005
|
Mycophenolic acid (as Mycophenolate sodium)
|
Mysod
|
360 mg
|
Delayed- Release Tablet
|
Immunosuppressant
|
Panacea Biotec Pharma Ltd.
|
India
|
Initial
|
21 February 2024
|
21 February 2029
|
| View |
|
DRP-14951
|
Cilostazol
|
Ostaz-50
|
50 mg
|
Tablet
|
Antiplatelet
|
4Care Lifescience Private Limited,
|
India
|
Initial
|
21 February 2024
|
21 February 2029
|
| View |
|
DR-XY49008
|
Dapagliflozin
|
Catania
|
5 mg
|
Film-Coated Tablet
|
Blood glucose lowering drug [Sodium-glucose co-
transporter 2 (SGLT2) inhibitor]
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 February 2024
|
22 February 2029
|
| View |
|
DR-XY49007
|
Dapagliflozin
|
Catania
|
10 mg
|
Film-Coated Tablet
|
Blood glucose lowering drug [Sodium-glucose co-
transporter 2 (SGLT2) inhibitor]
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 February 2024
|
22 February 2029
|
| View |
|
DRP-14956
|
Aspirin
|
Azper
|
80 mg
|
Tablet
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
22 February 2024
|
22 February 2029
|
| View |
|
DR-XY49006
|
Ascorbic Acid + Zinc
|
None
|
500 mg/ 20 mg (equivalent to 562.50 Sodium
ascorbate/54.89 mg Zinc sulfate monohydrate)
|
Capsule
|
Vitamin/Mineral
|
Hizon Laboratories, Inc.
|
Philippines
|
Initial (Correction)
|
13 May 2024
|
22 February 2029
|
| View |
|
DRP-14955
|
Acetylcysteine
|
Nacsyd
|
600 mg
|
Granules for Oral Solution
|
Mucolytic
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial (Corrections)
|
16 May 2024
|
22 February 2029
|
| View |
|
DRP-14941
|
Montelukast (as sodium)
|
Monteglob-4
|
4 mg
|
Chewable Tablet
|
Leukotriene receptor antagonist
|
Globela Pharma Private Limited
|
India
|
Initial
|
22 February 2024
|
22 February 2029
|
| View |
|
DRP-14893
|
Metformin Hydrochloride + Sitagliptin (as phosphate.
monohydrate)
|
Treviamet
|
500 mg/50 mg
|
Film- Coated Tablets
|
Antidiabetic
|
Baroque Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
22 February 2024
|
22 February 2029
|
| View |
|
DRP-14894
|
Metformin Hydrochloride + Sitagliptin (as phosphate.
monohydrate)
|
Treviamet
|
1 g/50 mg
|
Film-Coated Tablet
|
Antidiabetic Agent (Dipeptidyl peptidase 4 (DPP-4)
inhibitor/Biguanide)
|
Baroque Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
22 February 2024
|
22 February 2029
|
| View |
|
BR-1467
|
Avelumab
|
Bavencio
|
200 mg/10 mL (20 mg/mL)
|
Concentrate for Solution for
Infusion (IV)
|
Monoclonal Antibodies
|
Merck Serono SA
|
Switzerland
|
Monitored Release (MR)
|
22 February 2024
|
22 February 2029
|
| View |
|
DRP-14958
|
Enalapril maleate
|
Ollepril-10
|
10mg
|
Tablet
|
Angiotensin-converting-enzyme (ACE) Inhibitor
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
23 February 2024
|
23 February 2029
|
| View |
|
DRP-14957
|
Enalapril maleate
|
Ollepril-20
|
20 mg
|
Tablet
|
Angiotensin-Converting-Enzyme (ACE) Inhibitor
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
23 February 2024
|
23 February 2029
|
| View |
|
DR-XY49010
|
Vortioxetine (as hydrobromide)
|
Brintellix
|
20 mg/mL
|
Solution (Oral Drops)
|
Antidepressant
|
H. Lundbeck A/S
|
Denmark
|
Monitored Release
|
26 February 2024
|
26 February 2029
|
| View |
|
DRP-14809
|
Omeprazole
|
Onesin-40
|
40mg
|
Delayed-Release Capsule
|
Proton Pump Inhibitor
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
26 February 2024
|
26 February 2029
|
| View |
|
DR-XY49009
|
Nirmatrelvir + Ritonavir
|
Paxlovid
|
150 mg Film-Coated Tablet 100 mg
100 mg Film-Coated Tablet (Co-Packaged)
|
Film-Coated Tablets
|
Antiviral (Protease Inhibitor)
|
Pfizer Italia S.r.l
|
Italy
|
Monitored Release (FRP)
|
22 February 2024
|
22 February 2029
|
| View |
|
DRP-14942
|
Montelukast (as sodium)
|
Monteglob-5
|
5 mg
|
Chewable Tablet
|
Leukotriene receptor antagonist
|
Globela Pharma Private Limited
|
India
|
Initial
|
22 February 2024
|
22 February 2029
|
| View |
|
DRP-11848-07
|
Sitagliptin (as phosphate monohydrate) + Metformin Hydrochlorid
|
Diatech
|
50 mg / 500 mg
|
Film-Coated Tablet
|
Combination of Oral Blood Glucose Lowering Drugs
|
Fredun Pharmaceuticals Limited
|
India
|
CLIDP Conversion
|
05 February 2024
|
10 May 2027
|