| View |
|
DRP-14891
|
Rosuvastatin (as calcium)
|
Lipidbloc
|
20 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG CoA Reductase Inhibitor)
|
Healer's Lab (Unit II)
|
India
|
Initial
|
01 February 2024
|
01 February 2029
|
| View |
|
DR-XY48996
|
Fulvestrant
|
Fulveskal
|
50 mg/mL (250 mg/5 mL)
|
Solution for Injection (IM)
|
Anti-estrogen (Endocrine Therapy)
|
Chia Tai-Tianqing Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
02 February 2024
|
02 February 2029
|
| View |
|
DRHR-2335 (For Export Only)
|
Methyl Salicylate + Camphor +Menthol
|
Omega Pain Killer
|
15.775 g/ 4 g/ 3.33 g per 100 mL
|
Liniment
|
Counterirritant
|
International Pharmaceuticals Inc.
|
Philippines
|
Initial (Reconstruction)
|
20 March 2024
|
02 February 2026
|
| View |
|
DRHR-2332
|
Isopropyl Alcohol
|
Med+Guard
|
70mL per 100mL (70% v/v)
|
Topical Solution
(with moisturizer Lemon Lime scent)
|
Antiseptic/Disinfectant
|
Philko 18 Group of Companies Inc.
|
Philippines
|
Initial
|
02 February 2024
|
02 February 2029
|
| View |
|
DRP-14892
|
Tobramycin + Dexamethasone
|
Accetodex
|
3mg/1mg per mL
|
Ophthalmic Suspension (Eye Drops)
|
Antibacterial (Aminoglycoside)/Corticosteroid
|
Opal Laboratories (Pvt.) Limited.
|
Pakistan
|
Initial
|
01 February 2024
|
01 February 2029
|
| View |
|
DRHR-2339
|
Ethyl Alcohol
|
None
|
70 mL/100 mL (70% v/v)
|
Solution
|
Antiseptic/Disinfectant
|
Greenstone Pharmaceutical, Inc.
|
Philippines
|
Initial - HR
|
05 February 2024
|
05 February 2029
|
| View |
|
DRHR-2338
|
Ethyl Alcohol
|
Katinko Alco
|
70 mL/100 mL (70% v/v)
|
Solution
|
Antiseptic/Disinfectant
|
Greenstone Pharmaceutical, Inc.
|
Philippines
|
Initial HR
|
05 February 2024
|
05 February 2029
|
| View |
|
DRHR-2336
|
Ethyl Alcohol
|
Angel'S Flo
|
70 mL/100 mL (70% v/v)
|
Solution
|
Antiseptic/Disinfectant
|
C and H Cosmetics Industry
|
Philippines
|
Initial
|
05 February 2024
|
05 February 2029
|
| View |
|
DRHR-2337
|
Ethyl Alcohol
|
Angel'S Flo
|
70 mL/100 mL (70% v/v)
|
Solution
|
Antiseptic/Disinfectant
|
C and H Cosmetics Industry
|
Philippines
|
Initial
|
05 February 2024
|
05 February 2029
|
| View |
|
DRP-14900
|
Levetiracetam
|
Levtrazem
|
100 mg/mL
|
Solution For Injection (I.V.)
|
Antiepileptic
|
Makcur Laboratories Limited
|
India
|
Initial
|
06 February 2024
|
06 February 2029
|
| View |
|
DRP-14899
|
Ketamine (as hydrochloride)
|
Ketafree
|
50 mg/mL
|
Solution for Injection (IM/IV)
|
Other General Anesthetic
|
Makcur Laboratories Limited
|
India
|
Initial
|
06 February 2024
|
06 February 2029
|
| View |
|
DRHR-2334
|
Hydroquinone + Tretinoin
|
Skin Reborn
|
8.5 mg/60 mcg per gram
|
Topical Cream
|
Depigmenting Agent/Anti-acne
|
Beauche International Manufacturing Corporation
|
Philippines
|
Initial
|
06 February 2024
|
06 February 2029
|
| View |
|
DRHR-2333
|
Hydroquinone + Tretinoin
|
Skin Reborn
|
11 mg/50 mcg per mL
|
Topical Solution
|
Depigmenting Agent/Anti-acne
|
Beauche International Manufacturing Corporation.
|
Philippines
|
Initial
|
06 February 2024
|
06 February 2029
|
| View |
|
DRHR-2340
|
Isopropyl Alcohol
|
Med+Guard
|
70mL per 100mL (70% v/v)
|
Topical Solution
|
Antiseptic/ Disinfectant
(with moisturizer pure white scent)
|
Philko 18 Group of Companies Inc.
|
Philippines
|
Initial
|
06 February 2024
|
06 February 2029
|
| View |
|
DR-XY48997
|
Voriconazole
|
Vzonale
|
200 mg
|
Lyophilized Powder for Solution for Intravenous
(I.V.) Infusion
|
Triazole and Tetrazole Derivative
|
Kamla Life Sciences Limited
|
India
|
Initial (Reapplication)
|
06 February 2024
|
06 February 2029
|
| View |
|
DRP-14907
|
Rifampicin + Isoniazid + Pyrazinamide + Ethambutol
hydrochloride
|
Ripesaph-4
|
150 mg/75 mg/400 mg/275 mg
|
Film-Coated Tablet
|
Antituberculosis
|
Bueno Salud Care (India) Pvt. Ltd.
|
India
|
Initial
|
07 February 2024
|
07 February 2029
|
| View |
|
DRP-14906
|
Rifampicin + Isoniazid
|
Duasaph-300
|
300mg/150mg
|
Film-Coated Tablet
|
Antituberculosis
|
Bueno Salud Care (India) Pvt. Ltd.
|
India
|
Initial
|
07 February 2024
|
07 February 2029
|
| View |
|
DRP-14908
|
Oxaliplatin
|
Fin- Oxali 50
|
5 mg/mL (50 mg/10 mL)
|
Solution for Injection (I.V.)
|
Antineoplastic Agent (Platinum Compound)
|
Venus Remedies Limited
|
India
|
Initial
|
07 February 2024
|
07 February 2029
|
| View |
|
DRP-14909
|
Meropenem (as trihydrate)
|
Merpenem
|
1 g
|
Powder for Injection (I.V.)
|
Antibacterial (Carbapenem)
|
Venus Remedies, Limited
|
India
|
Initial
|
07 February 2024
|
07 February 2029
|
| View |
|
DRP-14910
|
Meropenem (as trihydrate)
|
Merpenem
|
500 mg
|
Powder for Injection (I.V.)
|
Antibacterial (Carbapenem)
|
Venus Remedies, Limited
|
India
|
Initial
|
07 February 2024
|
07 February 2029
|