| View |
|
DRP-12435
|
Iron
|
Fesusaph-15
|
15 mg (equivalent to 75 mg Ferrous Sulfate Heptahydrate)/0.6 mL
|
Syrup (Oral Drops) (Orange Flavor)
|
Mineral (Anti-anemia)
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial (OTC)
|
18 August 2022
|
18 August 2027
|
| View |
|
DRP-12520
|
Diclofenac (as diethylamine) + Methyl Salicylate + Levomenthol +Linum usitatissimum (Linseed) Seed
|
Diclomet
|
0.369g (1.16% w/w) / 3.150g (10% w/w) / 1.575g (5% w/w)
/ 0.318g (1% w/w) per 30g
|
Topical Gel
|
Non-steroidal Anti-inflammatory Drug
|
S Kant Healthcare Ltd.
|
India
|
Initial (Correction)
|
07 June 2024
|
26 August 2027
|
| View |
|
DRP-12515
|
Clopidogrel (as Bisulfate)
|
Plavido
|
75mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
25 August 2022
|
25 August 2027
|
| View |
|
DRP-12480
|
Bortezomib
|
Saphzomib
|
3.5mg
|
Lyophilized Powder For Injection (IV/SC)
|
Antineoplastic Agent (Proteasome inhibitor)
|
Bruck Pharma Private Limited
|
India
|
Initial
|
17 August 2022
|
17 August 2027
|
| View |
|
DRP-12479
|
Bortezomib
|
Saphzomib
|
1mg
|
Lyophilized Powder for Injection (IV/SC)
|
Antineoplastic Agent (Proteasome inhibitor)
|
Bruck Pharma Private Limited
|
India
|
Initial
|
17 August 2022
|
17 August 2027
|
| View |
|
DRP-12504
|
Sitagliptin (as Phosphate)
|
None
|
50 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
26 August 2022
|
26 August 2027
|
| View |
|
DRP-12502
|
Sitagliptin (as Phosphate)
|
None
|
100 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
26 August 2022
|
26 August 2027
|
| View |
|
DRP-12503
|
Sitagliptin (as Phosphate)
|
None
|
100 mg
|
Film-Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
26 August 2022
|
26 August 2027
|
| View |
|
DR-XY48314
|
Paclitaxel
|
None
|
6 mg/mL (300 mg/50 mL)
|
Solution for Injection
(IV Infusion)
|
Antineoplastic Agent (Taxane)
|
Eskayef Pharmaceuticals Limited - Rupganj Plant
|
Bangladesh
|
Initial
|
25 August 2022
|
25 August 2027
|
| View |
|
DR-XY48306
|
Piracetam
|
Embol
|
200 mg/mL
|
Solution For Injection (IM/IV)
|
Nootropics
|
Y.S.P. Industries (M) SDN. BHD.
|
Malaysia
|
Initial (Re-application)
|
22 August 2022
|
22 August 2027
|
| View |
|
DRP-12507
|
dl-Alpha Tocopherol (Vitamin E)
|
Vitmarie
|
400 I.U
|
Softgel Capsule
|
Vitamin
|
Titanium Technologies (India) Pvt. Ltd.
|
India
|
Initial
|
26 August 2022
|
26 August 2027
|
| View |
|
DRP-12519
|
Folic Acid
|
Pregnafol
|
5mg
|
Tablet
|
Vitamin (Anti-anemic)
|
Am-Europharma Corporation
|
Philippines
|
Initial
|
26 August 2022
|
26 August 2027
|
| View |
|
DRP-12508
|
Paracetamol
|
Equamol
|
500 mg
|
Effervescent Tablet (Lemon Flavor)
|
Analgesic / Antipyretic
|
Medley Pharmaceuticals Limited
|
India
|
Initial
|
26 August 2022
|
26 August 2027
|
| View |
|
DRP-1847-01
|
Vitamin B1 + Be + B12
|
Zervit
|
Formulation: Each tablet contains:
Thiamine Mononitrate (Vitamin B1)-100mg Pyridoxine Hydrochloride (Vitamin B6)-5mg Cyanocobalamin (Vitamin B12)-50mcg
|
Tablet
|
-
|
Square Pharmaceuticals, Inc.
|
Philippines
|
Renewal
|
25 August 2022
|
21 January 2027
|
| View |
|
DRP-12505
|
Acetylcysteine
|
Respifar
|
100 mg/mL
|
Solution For Inhalation
|
Mucolytic
|
PT. Pratapa Nirmala
|
Indonesia
|
Initial (Re-application)
|
22 August 2022
|
22 August 2027
|
| View |
|
DRP-12506
|
Ondansetron (As Hydrochloride)
|
Saphdosetron
|
2mg/ml (8mg/4ml) (4mg/2ml)
|
Solution For Injection (IM/IV)
|
Antiemetic/Antinauseant [Serotonin (5HT3) antagonist]
|
Bruck Pharma Private Limited
|
india
|
Initial
|
22 August 2022
|
22 August 2027
|
| View |
|
DRP-8727-02
|
Cetirizine Hydrochloride
|
Zetrigen
|
10mg
|
Film-Coated Tablet
|
Antihistamine
|
ACME Formulation Pvt. Ltd.
|
India
|
Initial [CLIDP) (Reapplication)
|
22 August 2022
|
12 February 2025
|
| View |
|
DR-XY48305
|
Losartan Potassium + Hydrochlorothiazide
|
Saranto- H
|
50mg/12.5mg
|
Film -Coated Tablet
|
Angiotensin II Receptor blocker (ARB)/ Diuretic
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial (Re-application)
|
19 August 2022
|
19 August 2027
|
| View |
|
DRP-12488
|
Amlodipine (As Besilate)
|
Dipinew
|
5 mg
|
Tablet
|
Selective Calcium Channel Blocker
|
Stallion Laboratories Pvt. Ltd.
|
India
|
initial
|
19 August 2022
|
19 August 2027
|
| View |
|
DRP-12489
|
Amlodipine (As Besilate)
|
None
|
5 mg
|
Tablet
|
Selective Calcium Channel Blocker
|
Stallion Laboratories Pvt. Ltd.
|
india
|
Initial
|
19 August 2022
|
19 August 2027
|