| View |
|
DRP-10874
|
Ceftriaxone (as sodium) + Sulbactam (as sodium
|
Du-Sulbac-1.5mg
|
1 g/500 mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Cephalosporin - Beta-Lactamase
Inhibitor Combination)
|
Theon Pharmaceuticals Limited
|
India
|
Monitored Release
|
10 December 2021
|
10 December 2026
|
| View |
|
DRP-10668
|
Betamethasone (as valerate)
|
Bl-Metason
|
1 mg/g (0.1% w/w)
|
Topical Cream
|
Corticosteroid
|
PT. Phapros Tbk
|
Indonesia
|
Initial
|
09 December 2021
|
09 December 2026
|
| View |
|
DR-XY47590
|
Pantoprazole (as sodium sesquihydrate)
|
Panvell
|
40 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
09 December 2021
|
09 December 2026
|
| View |
|
DRP-10838
|
Fulvestrant
|
Eranfu
|
250 mg/5 mL (50 mg/ ml)
|
Solution for Injection (I.M.)
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation Unit 9)
|
India
|
-
|
03 December 2021
|
03 December 2026
|
| View |
|
DRP-10873
|
Ceftriaxone (as sodium) + Sulbactam (as sodium)
|
Du-Sulbac 375
|
250 mg/125 mg
|
Powder for Injection (I.M./1.V.)
|
Antibacterial (Cephalosporin - Beta-Lactamase
Inhibitor Combination)
|
Theon Pharmaceuticals Limited
|
India
|
Monitored Release
|
10 December 2021
|
10 December 2026
|
| View |
|
DR-XY47604
|
Calcium folinate (as Folinic acid)
|
None
|
10 mg/mL
|
Solution for Injection/Infusion (I.M./I.V.)
|
Detoxifying Agent for Antineoplastic Treatment
|
Fresenius Kabi Austria GmbH
|
Austria
|
Initial
|
13 December 2021
|
13 December 2026
|
| View |
|
DRP-1288
|
Amlodipine (as besilate)
|
Amlodac
|
5 mg
|
Film Coated Tablet
|
Calcium Channel Blocker (Dihydropyridine derivative)
|
Cadila Healthcare Limited
|
India
|
Automatic Renewal
|
09 July 2023
|
19 August 2028
|
| View |
|
DRP-3183-04
|
Losartan (As Potassium)
|
Diassium 50
|
50 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blockers (ARBs)
|
XL Laboratories Pvt. Ltd.
|
India
|
-
|
08 March 2022
|
07 June 2027
|
| View |
|
DR-XY47598
|
Sertaconazole nitrate
|
Zalain
|
20 mg/g (2% w/w)
|
Topical Cream
|
Antifungal (Imidazole/Triazole Derivative)
|
Ferrer Internacional, S.A.
|
Spain
|
Monitored Release
|
10 December 2021
|
10 December 2026
|
| View |
DR-XY47600_PI_01.pdf
|
DR-XY47600
|
Doxofylline
|
Maxivent
|
400 mg
|
Tablet
|
Bronchodilator
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
10 December 2021
|
10 December 2026
|
| View |
|
DRHR-2109
|
Menthol + Camphor + Methyl Salicylate + Glycol
Salicylate + Diphenhydramine
|
Mentopas Air
|
5g/4.7g/2.72g/2.72g/60mg per 120mL
|
Aerosol
|
Counterirritant
|
Sinsin Pharmaceutical Co., Ltd.
|
Korea
|
Initial [HR]
|
02 December 2021
|
02 December 2026
|
| View |
|
DR-XY47579
|
Desflurane
|
Desflo
|
100% w/w Liquid for Inhalation
|
Liquid for Inhalation
|
General Anesthetic (Halogenated Hydrocarbon)
|
Shanghai Henrui Pharmaceutical Co., Ltd.
|
China
|
Monitored Release
|
03 December 2021
|
03 December 2024
|
| View |
|
DR-XY47508
|
Gabapentin
|
None
|
300 mg
|
Capsule
|
-
|
Korea United Pharm, Int'l JSC
|
Vietnam
|
-
|
02 December 2021
|
02 December 2026
|
| View |
|
DRP-10875
|
Moxifloxacin (as hydrochloride) + Dexamethasone
phosphate (as sodium)
|
Milflox Dm
|
5 mg/1 mg per mL (0.5%/0.1% w/v)
|
Sterile
Ophthalmic Solution
|
Anti-infective-Corticosteroid Combination
|
Sun Pharmaceutical Medicare Limited
|
India
|
Monitored Release
|
10 December 2021
|
10 December 2026
|
| View |
|
DR-XY 47599
|
Sertaconazole nitrate
|
Zalain Ovule
|
300 mg
|
Vaginal Suppository
|
Anti-infective/Antiseptic (Imidazole Derivative)
|
Trommsdorff GmbH & Co. KG
|
Germany
|
Monitored Release
|
10 December 2021
|
10 December 2024
|
| View |
BR-1382_PI_01.PDF
|
BR-1382
|
Moroctocog Alfa
|
Xyntha
|
250 IU
|
Lyophilized Powder for Injection (IV)
|
Blood coagulation factors
|
Wyeth Farma, S.A.
|
Spain
|
Monitored Release
|
10 December 2021
|
10 December 2026
|
| View |
BR-1383_PI_01.PDF
|
BR-1383
|
Moroctocog Alfa
|
Xyntha
|
500 IU
|
Lyophilized Powder for Injection (IV)
|
Blood coagulation factors
|
Wyeth Farma, S.A.
|
Spain
|
Monitored Release
|
10 December 2021
|
10 December 2026
|
| View |
|
DR-XY47596
|
Latanoprost
|
Xalaprost
|
50 mcg/mL (0.005% w/v)
|
Ophthalmic Solution (Drops)
|
-
|
Beximco Pharmaceuticals Ltd.
|
Bangladesh
|
-
|
09 December 2021
|
09 December 2026
|
| View |
|
DR-XY47595
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Unacilyn
|
1 g/500 mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Penicillin/Beta-lactamase inhibitor)
|
Karnataka Antibiotics & Pharma Ltd.
|
India
|
Initial
|
09 December 2021
|
09 December 2026
|
| View |
|
DR-XY47594
|
Tretinoin
|
Tretinon
|
500 mcg/g (0.05% w/w)
|
Topical Cream
|
Anti-acne
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial (OTC) [Correction]
|
21 January 2022
|
09 December 2026
|