| View |
|
DRP-10929
|
Norepinephrine (as bitartrate)
|
Blineph
|
1 mg/mL (4 mg/4 mL)
|
Solution for Injection (IV)
|
Adrenergic/Dopaminergic Agent
|
Makcur Laboratories Limited
|
India
|
Initial
|
31 January 2022
|
31 January 2027
|
| View |
|
DRP-11151
|
Cefuroxime Axetil
|
Zepreimex
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
08 February 2022
|
08 February 2027
|
| View |
|
DRP-564-01
|
Guaifenesin + Salbutamol (As Sulfate)
|
Salbumex
|
50mg/1mg per 5mL
|
Syrup
|
Expectorant
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
CLIDP
|
04 February 2022
|
19 June 2025
|
| View |
|
DRP-11149
|
Pregabalin
|
Lalaca
|
75mg
|
Capsule
|
Antiepileptic
|
Yooyoung Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
10 February 2022
|
10 February 2027
|
| View |
|
DRP-11153
|
Amlodipine (as besilate) + Atorvastatin (as calcium)
|
Dualpress
|
5 mg/10 mg
|
Film-Coated Tablet
|
Calcium Channel Blocker/HMG-CoA Reductase Inhibitor
|
Standard Chem. & Pharm. Co., Ltd. (Plant II)
|
Taiwan
|
Initial
|
08 February 2022
|
08 February 2027
|
| View |
|
DRP-11107
|
Ascorbic Acid + Zinc
|
Provitazee
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate) / 10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Vitamin/Mineral
|
Pharmatechnica Laboratory, Inc.
|
Philippines
|
Initial
|
02 February 2022
|
02 February 2027
|
| View |
|
DR-XY47695
|
Paracetamol + Caffeine
|
Panacaf
|
500mg/65mg
|
Film-Coated Tablet
|
Analgesic/Antipyretic
|
Medreich Limited (Unit 3)
|
India
|
Initial
|
07 February 2022
|
07 February 2027
|
| View |
|
DRP-11136
|
Paracetamol + Phenylephrine Hydrochloride +
Chlorpheniramine Maleate
|
Nasalnova
|
500 mg/10 mg/2 mg
|
Tablet
|
-
|
Saga Lifesciences Limited
|
India
|
-
|
04 February 2022
|
04 February 2027
|
| View |
|
DRP-11117
|
Ammonium Chloride + Diphenhydramine HCI
|
Bencodyl Linctus
|
135 mg/ 14 mg per 5 mL
|
Oral Liquid (Raspberry Flavor)
|
Antitussive/Antihistamine
|
KCK Pharmaceutical Industries SDN. BHD.
|
Malaysia
|
Initial
|
07 February 2022
|
07 February 2027
|
| View |
|
DRP-11116
|
Ascorbic Acid + Zinc
|
C-Max + Zn
|
500 mg (equivalent to 562.42 mg Sodium Ascorbate)/10 mg (equivalent to 27.5 mg Zinc Sulfate
Monohydrate)
|
Capsule
|
Vitamin / Mineral
|
Am-Europharma Corporation
|
Philippines
|
Initial
|
07 February 2022
|
07 February 2027
|
| View |
|
DRP-11102
|
Ascorbic Acid + Zinc
|
ImmunoCeeZinc
|
500 mg (Equivalent to 562.4 mg Sodium Ascorbate)/10 mg (equivalent to 24.7 mg Zinc
Sulfate)
|
Capsule
|
Vitamin/Mineral
|
Bauertek Corp.
|
Philippines
|
Initial
|
07 February 2022
|
07 February 2027
|
| View |
|
DR-XY47694
|
Ascorbic Acid + Zinc
|
Zeefence
|
500 mg (equivalent to 562.42 mg Sodium Ascorbate)/ 10 mg (equivalent to 27.5 mg Zinc Sulfate
Monohydrate)
|
Capsule
|
Vitamin/Mineral
|
AM-Europharma Corporation
|
Philippines
|
Initial
|
07 February 2022
|
07 February 2027
|
| View |
|
DRP-11135
|
Paracetamol
|
4Fever
|
125 mg/ 5 mL
|
Suspension (Orange Flavor)
|
Analgesic/ Antipyretic
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
04 February 2022
|
04 February 2027
|
| View |
|
DRHR-2125
|
Tretinoin + Hydroquinone
|
MXP Solution No. 3
|
25 mg/2 g per 100 mL (0.025%/2% w/v)
|
Solution
|
Anti-Acne (Retinoid)/Anti-hyperpigmentation
|
Splash Corporation
|
Philippines
|
Initial (Correction)
|
19 April 2023
|
08 February 2027
|
| View |
|
DRP-5427-04
|
Cetirizine Hydrochloride
|
Sitrizine
|
10 mg
|
Tablet
|
Antihistamine
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Renewal
|
31 August 2024
|
08 August 2029
|
| View |
|
DRP-9195-04
|
Ascorbic Acid + Zinc
|
Zitrin Plus
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate)/ 10 mg (equivalent 27.5 mg Zinc Sulfate Monohydrate)
|
Tablet
|
Vitamin/ Mineral
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Automatic Renewal (E-AR)
|
27 October 2023
|
02 October 2028
|
| View |
|
DRP-11150
|
Sitagliptin (as phosphate monohydrate) + Metformin
Hydrochloride
|
Sitag-M
|
50 mg/500 mg
|
Film-Coated Tablet
|
Antidiabetic Agent (Dipeptidyl peptidase 4 (DPP-4) inhibitor/Biguanide)
|
Bafna Pharmaceuticals Limited
|
India
|
Initial
|
08 February 2022
|
08 February 2027
|
| View |
|
DRP-11118
|
Loperamide + Simethicone
|
None
|
2 mg/125 mg Tablet
|
Tablet
|
Antipropulsive/Antiflatulent
|
Indeus Life Sciences Pvt. Ltd.
|
India
|
Initial
|
07 February 2022
|
07 February 2027
|
| View |
|
DRP-11148
|
Telmisartan
|
None
|
80 mg
|
Tablet
|
-
|
Aurobindo Pharma Limited (Unit VII)
|
India
|
-
|
10 February 2022
|
10 February 2027
|
| View |
|
DRP-11155
|
Octreotide (as acetate)
|
Otide 50
|
50 mcg/mL
|
Solution for Injection (IV Infusion/SC)
|
Hypothalamic Hormone (Somatostatin and
Analogues)
|
United Biotech Pvt. Ltd.
|
India
|
Initial
|
08 February 2022
|
08 February 2027
|