| View |
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DR-XY47453
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Bendamustine hydrochloride
|
Bemunat 100
|
100mg
|
Lyophilized Powder for Concentrate for
Solution for I.V. Infusion
|
-
|
Natco Pharma Limited
|
India
|
Monitored Release (Reconstruction)
|
11 November 2022
|
12 October 2026
|
| View |
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DR-XY47454
|
Bendamustine hydrochloride
|
Bemunat 25
|
25mg
|
Lyophilized Powder for Concentrate for
Solution for I.V. Infusion
|
-
|
Natco Pharma Limited
|
India
|
Monitored Release (Reconstruction)
|
11 November 2022
|
12 October 2026
|
| View |
|
DRP-9318
|
Exemestane
|
Exetas 25
|
25mg
|
Film Coated Tablet
|
-
|
Intas Pharmaceuticals Limited
|
India
|
-
|
14 October 2021
|
14 October 2026
|
| View |
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DRP-6356-05
|
Co-Amoxiclav
|
Cosmox 312.5
|
250 mg/62.5 mg per 5 mL
|
Powder For Suspension
|
-
|
Pil Pharmaceuticals Pvt. Ltd.
|
India
|
Initial (Reissuance)
|
29 July 2022
|
02 October 2025
|
| View |
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DR-XY47450
|
Leuprorelin Acetate
|
None
|
11.25mg
|
Lyophilized Powder For Injection (I.M./S.C.)
|
-
|
Dongkook Pharmaceutical Co., Ltd.
|
Korea
|
-
|
11 October 2021
|
11 October 2026
|
| View |
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DR-XY47461
|
Bimatoprost
|
None
|
300 mcg/mL (0.03% w/v)
|
Ophthalmic Solution (Eye Drops)
|
Anti-glaucoma/Miotic (Prostaglandin Analogue)
|
Beximco Pharmaceuticals Limited
|
Bangladesh
|
Initial
|
13 October 2021
|
13 October 2026
|
| View |
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DR-XY47452
|
R-Thioctic Acid Tromethamine
|
Kalxid
|
480 mg Tablet (equivalent to 300 mg R-Thioctic acid)
|
Tablet
|
-
|
Bukwang Pharmaceutical Co., Ltd.
|
Korea
|
-
|
11 October 2021
|
11 October 2026
|
| View |
|
DRP-2798-01
|
Atorvastatin (As Calcium)
|
None
|
20 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitor
|
Agio Pharmaceuticals Ltd.
|
India
|
CLIDP (Compliance)
|
08 October 2021
|
13 July 2026
|
| View |
|
DRP-10509
|
Baclofen
|
Fenobac
|
10 mg
|
Tablet
|
-
|
Eskayef Bangladesh Limited
|
Bangladesh
|
Initial
|
08 October 2021
|
08 October 2026
|
| View |
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DRP-10552
|
Heparin Sodium + Allium cepa L. (Onion) Bulb
Allantoin
|
Scartubex
|
50 I.U./100mg/10mg per g
|
Topical Gel
|
-
|
Kolmar Korea Co., Ltd.
|
Korea
|
-
|
15 October 2021
|
15 October 2026
|
| View |
|
HRP-465
|
Turpentine oil, Capsicum oleoresin, Sanguis draconis (Daemonorops draco fruit), Methyl salicylate
|
Axe Brand Red Flower Oil
|
Each 100 mL Topical solution contains:
Turpentine oil
22 mL Capsicum oleoresin
1 mL Sanguis draconis (Daemonorops draco fruit) 30 mg Methyl salicylate
qs to 100 mL
|
Topical Solution
|
Counterirritant
|
Leung Kai Fook Medical Co Pte Ltd
|
Singapore
|
Renewal
|
07 August 2024
|
08 October 2029
|
| View |
DR-XY47451_PI_01.pdf
|
DR-XY47451
|
Salmeterol (as xinafoate) + Fluticasone propionate
|
Saltrol
|
25mcg + 250mcg mcg per Actuation Metered Dose
|
Pressurized Liquid for Inhalation
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
-
|
14 October 2021
|
14 October 2026
|
| View |
DR-XY47462_PI_01.pdf
|
DR-XY47462
|
Salmeterol (as xinafoate) + Fluticasone propionate
|
Saltrol
|
25 mcg/125mcg per Actuation Metered Dose
|
Pressurized
Liquid for Inhalation
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
-
|
14 October 2021
|
14 October 2026
|
| View |
|
DRP-9801
|
Domperidone (as maleate)
|
Gasdone
|
10mg
|
Film-Coated Tablet
|
-
|
Zim Laboratories Limited
|
India
|
-
|
14 October 2021
|
14 October 2026
|
| View |
|
DRP-10538
|
Cefoperazone (As Sodium) + Sulbactam (As Sodium)
|
Cefbac
|
1g/500mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Cephalosporin-Beta-Lactamase Inhibitor Combination)
|
Theon Pharmaceuticals Limited
|
India
|
Initial
|
14 October 2021
|
14 October 2026
|
| View |
|
DR-XY20187-B
|
Amoxicillin(As Trihydrate)
|
Supramox
|
250mg/5mL
|
Powder For Suspension
|
Antibacterial (Penicillin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Renewal
|
23 May 2022
|
23 June 2027
|
| View |
|
DRHR-2064
|
Povidone Iodine+Psidium Guajava L. (Guava) Leaf
|
Guavidone
|
100mg/100mg per mL
|
Topical Solution
|
-
|
La Croesus Pharma, Inc.
|
Philippines
|
-
|
15 October 2021
|
15 October 2026
|
| View |
|
DR-XY7268
|
Benzoic acid + Resorcinol + Salicylic acid + Iodine
|
Bonil Solution
|
50mg/50mg/50mg/10mg per mL
|
Solution
|
Antifungal
|
The Plantilla Corporation
|
Philippines
|
Renewal
|
16 November 2023
|
09 December 2028
|
| View |
|
DRP-10524
|
Mannitol
|
Axatol-20
|
200mg/mL (20%w/v)
|
Solution For IV Infusion
|
Diuretic
|
Axa Parenterals Limited.
|
India
|
Initial (Reconstruction)
|
12 August 2024
|
11 October 2026
|
| View |
|
DRP-10428
|
Cefixime (as Trihydrate)
|
Zefimed
|
400mg
|
Capsule
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
-
|
13 October 2021
|
13 October 2026
|