| View |
|
DRHR-2212
|
Turmeric Oil+ Menthol
|
HP Mint Rub
|
2.5 g/1 g per 10 g
|
Liniment
|
-
|
Greatlab Pharmaceutical
|
Philippines
|
Initial
|
02 March 2023
|
02 March 2025
|
| View |
|
DRP-13499
|
Amikacin (as sulfate)
|
Amikacy-250
|
250 mg/mL
|
Solution for Injection (I.M./I.V.)
|
-
|
Hiral Labs Limited
|
India
|
Initial
|
28 February 2023
|
28 February 2028
|
| View |
|
DRP-13498
|
Amikacin (as sulfate)
|
Amikacy-125
|
125 mg/mL
|
Solution for Injection (I.M./I.V.)
|
-
|
Hiral Labs Limited
|
India
|
Initial
|
28 February 2023
|
28 February 2028
|
| View |
DR-XY48635_PI_01.pdf
|
DR-XY48635
|
Bedaquiline (as Fumarate)
|
Sirturo
|
20 mg
|
Tablet
|
-
|
Recipharm Pharmaservices Pvt. Ltd.
|
India
|
Monitored Release
|
23 February 2023
|
23 February 2028
|
| View |
|
DRP-13410
|
Paracetamol + Phenylpropanolamine (as hydrochloride) +
Chlorpheniramine maleate
|
Flusaph-Forte
|
500 mg / 25 mg / 2 mg
|
Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd..
|
India
|
Initial (Correction)
|
28 April 2023
|
27 February 2028
|
| View |
|
DR-XY48639
|
Multivitamins + Minerals
|
None
|
Formulation:
Each Effervescent tablet contains:
Thiamine Mononitrate (Vitamin B1) 1.5 mg Riboflavin (Vitamin B2) 1.5 mg
Pyridoxine (Vitamin B6) 1.5 mg
Cyanocobalamin (Vitamin B12) 3 mcg
dl-a-Tocopheryl acetate (Vitamin E)60 IU
Niacinamide 10 mg
Biotin 30 mcg
Calcium D-Pantothenate 5mg
Folic Acid 400 mcg
|
Effervescent Tablet
(Pomelo Flavor)
|
-
|
Yuesheng Biotech Co., Ltd.
|
Taiwan
|
Initial
|
02 March 2023
|
02 March 2028
|
| View |
|
DRP-13488
|
Hydroquinone
|
Melite
|
40 mg/g (4% w/w)
|
Topical Cream
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial (OTC)
|
27 February 2023
|
27 February 2028
|
| View |
|
DRP-13506
|
Ascorbic Acid + Zinc
|
GolCinc Forte
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate)/40
mg (equivalent to 109.8 mg Zinc Sulfate Monohydrate)
|
Capsule
|
-
|
Phil. United Pharma Corporation
|
Philippines
|
Initial (OTC)
|
02 March 2023
|
02 March 2028
|
| View |
|
DRHR-2211
|
Ethyl Alcohol
|
Huntergreen
|
70% (v/v)
|
Topical Solution
|
-
|
Kohl Industries Corporation.
|
Philippines
|
Initial
|
15 February 2023
|
15 February 2028
|
| View |
|
DRP-13461
|
Glimepiride
|
Novaglim
|
2 mg
|
Tablet
|
-
|
Acme Formulation Pvt. Ltd.
|
India
|
Initial (Re-application)
|
23 February 2023
|
23 February 2028
|
| View |
|
DRHR-2210
|
Isopropyl Alcohol
|
Hygienix
|
70 % (v/v)
|
Topical Solution
|
-
|
Splash Corporation
|
Philippines
|
Initial (Reconstruction)
|
27 February 2023
|
27 February 2028
|
| View |
|
DRP-13467
|
Prednisone
|
Prednisaph-20
|
20 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
23 February 2023
|
23 February 2028
|
| View |
|
DRP-13468
|
Prednisone
|
Prednisaph-10
|
10 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
23 February 2023
|
23 February 2028
|
| View |
|
DRP-13501
|
Atorvastatin (as calcium trihydrate)
|
Madrovas-20
|
20 mg
|
Film-Coated Tablet
|
-
|
The Madras Pharamceuticals
|
India
|
Initial
|
02 March 2023
|
02 March 2028
|
| View |
|
DRP-13492
|
Valsartan + Amlodipine (as besilate)
|
Vaspin
|
80mg/5mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
27 February 2023
|
27 February 2028
|
| View |
|
DRP-13491
|
Valsartan + Amlodipine (as besilate)
|
Vaspin
|
160 mg/5 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
27 February 2023
|
27 February 2028
|
| View |
|
DRP-13490
|
Valsartan + Amlodipine (as besilate)
|
Vaspin
|
160 mg/10 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
27 February 2023
|
27 February 2028
|
| View |
|
DRP-13507
|
Azithromycin (as dihydrate)
|
Zikant
|
200 mg/5 mL
|
Powder For Oral Suspension
|
-
|
S Kant Healthcare Limited
|
India
|
Initial
|
02 March 2023
|
02 March 2028
|
| View |
|
DRP-13469
|
Mupirocin
|
PiroMed
|
20 mg/g (2% w/w)
|
Ointment
|
-
|
Rhydburg Pharmaceuticals Ltd.
|
India
|
Initial
|
23 February 2023
|
23 February 2028
|
| View |
|
DRP-13494
|
Oxymetazoline Hydrochloride
|
Nasathix
|
500 mcg/mL (0.05% w/v)
|
Nasal Spray
|
Nasal Decongestant
|
Biodeal Pharmaceuticals Pvt. Ltd.
|
India
|
Renewal
|
09 October 2024
|
28 February 2030
|