| View |
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DR-XY48047
|
Ascorbic Acid + Zinc + Cholecalciferol (Vitamin D3)
|
Vitammune
|
500 mg (Equivalent to 562.43 mg Sodium Ascorbate)/10mg
(Equivalent to 70 mg Zinc Gluconate )/1000 IU
|
Capsule
|
Vitamin/ Mineral
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
31 May 2022
|
31 May 2027
|
| View |
|
DRP-12019
|
Tretinoin
|
Blanc By Beautederm Acne Banishing
|
0.06 mcg (0.006% w/w) per 100 g
|
Cream
|
Anti-Acne
|
DJM Grandeur Corporation
|
Philippines
|
Initial
|
31 May 2022
|
31 May 2027
|
| View |
|
DRP-12012
|
Montelukast (as sodium) + Levocetirizine
hydrochloride
|
Montellion-L
|
10 mg / 5 mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist-Antihistamine
Combination
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Monitored Release (Re-application)
|
30 May 2022
|
30 May 2027
|
| View |
DRP-12013_PI_01.pdf
|
DRP-12013
|
Risperidone
|
Amidrex OD-3
|
3 mg
|
Orally Disintegrating Tablet
|
Antipsychotic
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Monitored Release (Re-application)
|
30 May 2022
|
30 May 2027
|
| View |
DRP-12014_PI_01.pdf
|
DRP-12014
|
Risperidone
|
Amidrex OD-4
|
4 mg
|
Orally Disintegrating Tablet
|
Antipsychotic
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Monitored Release (Re-application)
|
30 May 2022
|
30 May 2027
|
| View |
|
DR-XY48068
|
Testosterone
|
Androgel
|
1 mg/g (1% w/w)
|
Transdermal Gel
|
Androgen [3-oxoandrosten (4) derivative]
|
Delpharm Drogenbos S.A.
|
Belgium
|
Monitored Release (Re-application)
|
30 May 2022
|
30 May 2027
|
| View |
|
DRP-3264-05
|
Paracetamol/Vitamin B1/ Vitamin B6/Vitamin B12
|
Paranerve Plus
|
500 mg/50 mg/100 mg/100 mcg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc. No.
|
Philippines
|
Automatic Renewal
|
27 May 2022
|
20 May 2027
|
| View |
|
DRP-3264-02
|
Paracetamol/Vitamin B1/ Vitamin B6/Vitamin B12
|
Benerva Plus
|
500 mg/50 mg/100 mg/100 mcg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
27 May 2022
|
20 May 2027
|
| View |
|
DRP-12008
|
Metronidazole
|
Xylomid
|
500 mg
|
Tablet
|
Antibacterial/Antiprotozoal (Nitroimidazole Derivative)
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
30 May 2022
|
30 May 2027
|
| View |
|
DRP-12002
|
Dorzolamide (as hydrochloride)
|
Optador
|
20 mg/mL (2% w/v)
|
Sterile Ophthalmic Solution (Eye Drops)
|
Antiglaucoma (Carbonic Anhydrase Inhibitor)
|
World Medicine İlaç Sanayi Ve Ticaret A.Ş
|
Turkey
|
Initial
|
27 May 2022
|
27 May 2027
|
| View |
|
DRP-11961
|
Simvastatin
|
None
|
10 mg
|
Film-Coated Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
24 May 2022
|
24 May 2027
|
| View |
|
DRP-11960
|
Simvastatin
|
None
|
20 mg
|
Film-Coated Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
24 May 2022
|
24 May 2027
|
| View |
|
DRP-11959
|
Simvastatin
|
None
|
40 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitor
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
24 May 2022
|
24 May 2027
|
| View |
|
DRP-11930
|
Hydrocortisone
|
Edrocort
|
10 mg/g (1% w/w)
|
Cream
|
Topical Corticosteroid
|
Kremoint Pharma Pvt. Ltd.
|
India
|
Initial
|
23 May 2022
|
23 May 2027
|
| View |
|
DRP-12007
|
Thiamine hydrochloride (Vitamin B1) + Pyridoxine
hydrochloride (Vitamin B6) + Cyanocobalamin (Vitamin
B12)
|
Bomplex
|
100 mg/100 mg/1 mg per 3 mL
|
Solution for Injection
(IV)
|
Vitamins
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
30 May 2022
|
30 May 2027
|
| View |
|
DR-XY48035
|
Ascorbic Acid + Zinc
|
None
|
500mg (equivalent to 605.327mg Calcium Ascorbate) / 10mg (equivalent to 75.93 mg Zinc Gluconate)
|
Capsule
|
Vitamin/Mineral
|
Northfield Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
23 May 2022
|
23 May 2027
|
| View |
|
DRP-11916
|
Rocuronium Bromide
|
Fironium
|
10 mg/mL
|
Solution for Injection (IV)
|
Muscle Relaxant
|
PT. Bernofarm
|
Indonesia
|
Initial
|
30 May 2022
|
30 May 2027
|
| View |
|
DRP-12010
|
Ceftriaxone (as sodium)
|
Infiobiotic
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (third generation cephalosporin)
|
PT. Bernofarm
|
Indonesia
|
Initial
|
30 May 2022
|
30 May 2027
|
| View |
|
DRP-11986
|
Thiamine Mononitrate (Vitamin B1) + Pyridoxine HCl
(Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
Nishanerv
|
300 mg/300 mg/1 mg
|
Capsules
|
Vitamin
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DRP-11924
|
Cloxacillin (As Sodium)
|
Cloxasaph-500
|
500 mg
|
Capsule
|
Antibacterial (Beta-lactamase resistant penicillin)
|
Sunlovis Pharmaceuticals LLP
|
India
|
Initial (Correction)
|
30 July 2024
|
20 May 2027
|