| View |
|
DRP-12680
|
Miconazole
|
Miconarex
|
20mg/g (2% w/w)
|
Cream
|
Antifungal
|
Next Wave (India)
|
India
|
Initial (OTC)
|
22 September 2022
|
22 September 2027
|
| View |
|
DR-XY48374
|
Calcium + Cholecalciferol
|
CALVIMIN
|
500 mg/ 400 IU
|
Film-Coated Tablet
|
Mineral/Vitamin
|
The Acme Laboratories Limited
|
Bangladesh
|
Initial (OTC)
|
23 September 2022
|
23 September 2027
|
| View |
|
DRP-12601
|
Febuxostat
|
Afixostat 40
|
40 mg
|
Film-Coated Tablet
|
Antigout
|
Sunrise International Labs Limited
|
India
|
Initial
|
14 September 2022
|
14 September 2027
|
| View |
|
DRP-12634
|
Phenylephrine Hydrochloride + Chlorphenamine Maleate
|
Saphendrine-6.25
|
6.25 mg/0.5 mg per 5 mL
|
Syrup
|
Decongestant/Antihistamine
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
16 September 2022
|
16 September 2027
|
| View |
|
DRP-12712
|
Diosmin + Hesperidin
|
Hesminsaph-500
|
450 mg/50 mg
|
Film-Coated Tablet
|
Vasoprotective
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
28 September 2022
|
28 September 2027
|
| View |
|
DRP-12711
|
Diosmin + Hesperidin
|
Hesminsaph-1000
|
900 mg/100 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (OTC)
|
28 September 2022
|
28 September 2027
|
| View |
|
DRHR-2152
|
Oral Rehydration Salts
|
Khriz-Ors
|
Formulation: Each sachet (20.5 g) contains: Sodium Chloride-2.6 g Potassium Chloride-1.5g Sodium Citrate-2.9g Anhydrous Glucose-13.5g
|
Powder For Oral Solution
|
Electrolyte Replenisher
|
Reyoung Pharmaceutical Co. Ltd.
|
China
|
Initial (HR)
|
19 September 2022
|
19 September 2027
|
| View |
|
DR-XY48350
|
Ascorbic Acid
|
None
|
1 g
|
Effervescent Tablet (Passion Fruit Flavor)
|
Vitamin
|
Yue-Sheng Biotech Co., Ltd.
|
Taiwan
|
Initial (OTC)
|
20 September 2022
|
20 September 2027
|
| View |
|
DR-XY48368
|
Paracetamol
|
Khrizgesic
|
500mg
|
Tablet
|
Analgesic/Antipyretic
|
Merit Organics Ltd.
|
India
|
Initial (OTC)
|
22 September 2022
|
22 September 2027
|
| View |
|
DR-XY48369
|
Paracetamol + Phenylephrine Hydrochloride (Day Tablet)
and Paracetamol + Phenylephrine Hydrochloride +
Chlorpheniramine Maleate (Night Tablet)
|
Sinutab Cold Day & Night
|
500mg/5mg Film-coated Tablet (Day Tablet);
500mg/5mg / 2mg Film-coated Tablet (Night Tablet)
|
Film-Coated Tablet
|
Analgesic/Antipyretic/Nasal Decongestant;
Analgesic/Antipyretic/Nasal Decongestant/Antihistamine
|
Probiotec Pharma Pty Limited
|
Australia
|
Initial (OTC) (Reapplication) (Reconstruction
|
18 January 2023
|
22 September 2027
|
| View |
|
DRHR-2148
|
Methyl Salicylate+ Menthol + Camphor
|
Katinko (Ginger & Patchouli Oil Scent)
|
2.0g / 2.0g /2.0g per 100 mL
|
Liniment
|
-
|
Greenstone Pharmaceutical, Inc.
|
Philippines
|
Initial
|
27 September 2022
|
27 September 2027
|
| View |
|
DR-XY48358
|
Ascorbic Acid + Colecalciferol (Vitamin D3) + Zin
|
Tri-Protect
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate)/
1000 IU/ 10 mg (equivalent to 70.00 mg Zinc
Gluconate)
|
Capsule
|
Vitamins/Mineral
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
16 September 2022
|
16 September 2027
|
| View |
BR-1421_PI_01.pdf
|
BR-1421
|
Quadrivalent Seasonal Influenza Vaccine (Split Virion, Inactivated) 2024 Southern Hemisphere Strain.
|
Fluquadri
|
Each dose (0.5 mL) contains the following influenza strains*:
A/Victoria/4897/2022 (H1N1) pdm09-like strain 15 μg of HA**
(A/Victoria/4897/2022, IVR-238)
A/Thailand/8/2022 (H3N2)-like strain
15 μg of HA**
(A/California/122/2022, SAN-022) B/Austria/1359417/2021-like strain
15 μg of HA**
(B/Michigan/01/2021, wild type)
B/Phuket/3073/2013 (B/Yamagata lineage)-like virus
15 μg of HA**
(B/Phuket/3073/2013, wild type)
*Propagated in embryonated chicken eggs
**Haemagglutinin
|
Suspension for Injection (IM)
|
Vaccines
|
Sanofi Pasteur
|
U.S.A
|
Monitored Release (Strain Clearance)
|
27 March 2024
|
27 March 2025
|
| View |
|
DRP-12653
|
Ofloxacin
|
Ibles
|
3 mg/mL (0.3% w/v)
|
Ophthalmic Solution
|
Antibacterial (Fluoroquinolone)
|
Makcur Laboratories Limited
|
India
|
Initial
|
19 September 2022
|
19 September 2027
|
| View |
|
HRP-550
|
Ethyl Alcohol + Chlorhexidine Gluconate
|
Bio-Guard
|
70% v/v / 0.5% w/v
|
Topical Solution
|
Antiseptic/Disinfectant
|
Nagindas Hiralal Bhayani
|
India
|
Initial
|
28 September 2022
|
28 September 2027
|
| View |
|
HRP-545
|
Ethyl Alcohol
|
Etheral
|
70% v/v
|
Solution
|
Antiseptic/Disinfectant
|
Nagindas Hiralal Bhayani
|
India
|
Initial
|
19 September 2022
|
19 September 2027
|
| View |
|
HRP-544
|
Isopropyl Alcohol
|
Iso-Guard
|
70% v/v
|
Solution
|
Antiseptic/Disinfectant
|
Nagindas Hiralal Bhayani
|
India
|
Initial
|
19 September 2022
|
19 September 2027
|
| View |
|
HRP-546
|
Povidone-Iodine
|
Povide
|
10% w/v
|
Topical Solution
|
Antiseptic/Disinfectant
|
Nagindas Hiralal Bhayani
|
India
|
Initial
|
19 September 2022
|
19 September 2027
|
| View |
|
DRP-12641
|
Terbinafine Hydrochloride
|
Terbifred
|
10 mg/g (1% w/w)
|
Topical Cream
|
Antifungal
|
Fredun Pharmaceuticals Limited
|
India
|
Initial (OTC)
|
19 September 2022
|
19 September 2027
|
| View |
|
DRP-12643
|
Miconazole Nitrate
|
Micofred
|
20 mg/g (2% w/w)
|
Topical Cream
|
Antifungal
|
Fredun Pharmaceuticals Limited
|
India
|
Initial (OTC)
|
19 September 2022
|
19 September 2027
|