| View |
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DR-XY48428
|
Vancomycin (as hydrochloride)
|
Vamicyn
|
500 mg
|
Powder for IV Infusion
|
-
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
DRP-12796_PI_01.pdf
|
DRP-12796
|
Metronidazole + Miconazole Nitrate
|
Neo-Penotran
|
500mg / 100mg
|
Vaginal Suppository
|
Anti-infective/Antiseptic/Antifungal
|
Exeltis Ilac San. Ve Tic. A.S.
|
Turkey
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
DRP-12795_PI_01.pdf
|
DRP-12795
|
Metronidazole + Miconazole Nitrate
|
Neo-Penotran Forte
|
750mg / 200mg
|
Vaginal Suppository
|
Anti-infective/Antiseptic/Antifungal
|
Exeltis Ilac San. Ve Tic. A.S.
|
Turkey
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
DRP-12794_PI_01.pdf
|
DRP-12794
|
Metronodazole + Miconazole Nitrate + Lidocaine
|
Neo-Penotran Forte-L
|
750mg / 200mg / 100mg
|
Vaginal Suppository
|
Anti-infective/Antiseptic/Antifungal/Anesthetic
|
Exeltis Ilac San. Ve Tic. A.S.
|
Turkey
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12843
|
Loratadine
|
Sydenhist
|
5 mg
|
Chewable Tablet (Grape Flavor)
|
Antihistamine
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial [OTC][PCPR] (Correction)
|
17 November 2022
|
14 October 2027
|
| View |
|
HRP-551
|
Povidone-Iodine
|
Rexvidone
|
50 mg/g (5%w/w)
|
Cream
|
Antiseptic
|
Jiangxi Xierkangtai Pharmaceutical Co., Ltd.
|
China
|
Initial (HR)
|
10 October 2022
|
10 October 2027
|
| View |
|
DRP-12706
|
Mupirocin
|
Bactrexin
|
20mg/g (2% w/w)
|
Ointment
|
Antibacterial
|
Next Wave (India)
|
India
|
Initial (OTC)
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12834
|
Diclofenac sodium (equivalent to Diclofenac diethylamine)
|
Coxyn
|
10 mg/g (1%w/w)
|
Topical Gel
|
Non-steroidal Antiinflammatory Drug (NSAID)
(Propionic Acid Derivative)
|
Lincoln Pharmaceuticals Ltd.
|
India
|
Initial
|
12 October 2022
|
12 October 2027
|
| View |
DR-XY48413_PI_01.pdf
|
DR-XY48413
|
Trifarotene
|
Aklief
|
50 mcg/g
|
Cream
|
Anti-Acne
|
Laboratories Galderma
|
France
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
|
DR-XY48421
|
Ascorbic Acid + dl-Alpha Tocopheryl Acetate
(Vitamin E)
|
MyBeaute
|
500 mg / 12 mg per Capsule
|
Capsule
|
Vitamins
|
Compact Pharmaceuticals, Corp.
|
Philippines
|
Initial (OTC)
|
13 October 2022
|
13 October 2027
|
| View |
|
BR-1426
|
Epoetin Alfa
|
Erysaa
|
2,000 IU/0.5 mL
|
Solution for Injection (IV)
|
Antianemic Preparations
|
PanGen Biotech Inc.
|
Korea
|
Initial
|
17 October 2022
|
17 October 2027
|
| View |
DR-XY48414_PI_01.pdf
|
DR-XY48414
|
Sodium Chloride
|
Axaline 3.0%
|
30mg/mL (3% w/v)
|
Solution for Intravenous Infusion
|
Hypertonic Solution
|
Axa Parenterals Limited
|
India
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
|
DR-XY48416
|
Vitamin B-Complex
|
None
|
Formulation:
Each capsule contains:
Thiamine Hydrochloride (Vitamin B)..........50 mg Riboflavin (Vitamin B2)...........................50 mg Niacinamide (Vitamin B1).....................50 mg Pantothenic Acid (Vitamin Bs)..................50 mg Pyridoxine Hydrochloride (Vitamin B.).......50 mg Para-aminobenzoic acid (PABA)...............50 mg
Folic Acid (Vitamin B,)................1 mg Biotin (Vitamin B7).............................60 mcg Cyanocobalamin (Vitamin B12)............50 mcg Choline Bitartrate............. 50 mg Inositol............... 50 mg
|
Capsule
|
Vitamins
|
Factors Group of Nutritional Companies Inc.
|
Canada
|
Initial (Re-Application)
|
13 October 2022
|
13 October 2027
|
| View |
|
DRP-12838
|
Ascorbic acid + Colecalciferol (Vitamin D3) + Zinc
|
Rapid-C Plus D1000
|
500 mg (equivalent to 562.50 mg Sodium Ascorbate)
/1000 IU/10 mg (equivalent to 70 mg Zinc Gluconate)
|
Capsule
|
Vitamin/Mineral
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (OTC)
|
13 October 2022
|
13 October 2027
|
| View |
|
DRP-12839
|
Ascorbic acid + Colecalciferol (Vitamin D3) + Zinc
|
None
|
500 mg (equivalent to 562.50 mg Sodium Ascorbate) /1000 IU/10 mg (equivalent to 70 mg Zinc Gluconate)
|
Capsule
|
Vitamin/Mineral
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
13 October 2022
|
13 October 2027
|
| View |
|
DRP-12790
|
d-Alpha Tocopherol (Vitamin E)
|
Dermavit-E
|
400 IU
|
Softgel Capsule
|
Vitamin
|
Qingdao Sunrise Health Co., Limited
|
China
|
Initial (OTC)
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12803
|
Piracetam
|
Saphcetam-800
|
800mg
|
Film-Coated Tablet
|
Nootropic (Other Psychostimulant and Nootropic)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12802
|
Piracetam
|
Saphcetam-1.2
|
1200 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12860
|
Carvedilol
|
Carvesaph
|
12.5 mg
|
Film-Coated Tablet
|
Alpha and Beta Blocking Agent
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
17 October 2022
|
17 October 2027
|
| View |
DR-XY48371_PI_01.pdf
|
DR-XY48371
|
Nilotinib (as hydrochloride dihydrate)
|
Nicmel 200
|
200mg
|
Capsules
|
Antineoplastic agent (BCR-ABL tyrosine kinase inhibitor)
|
Hetero Labs Limited (Unit V and Unit V-A)
|
India
|
Monitored Release (Re-application)
|
11 October 2022
|
11 October 2027
|