| View |
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DR-XY48348
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Flupentixol Decanoate
|
Flupenxol
|
20mg/mL
|
Solution for Injection (IM)
|
Antipsychotic (Thioxanthene derivative)
|
Ciron Drugs & Pharmaceuticals Pvt. Limited
|
india
|
Initial
|
13 September 2022
|
13 September 2027
|
| View |
DR-XY48349_PI_01.pdf
|
DR-XY48349
|
Emtricitabine + Dolutegravir (as sodium) + Tenofovir The alafenamide (as hemifumarate)
|
None
|
200 mg/50 mg/25 mg
|
Film-Coated Tablet
|
Antiretroviral (Direct Acting Antivirals)
|
Hetero Labs Limited (Unit III)
|
India
|
Monitored Release (MR
|
13 September 2022
|
13 September 2027
|
| View |
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DR-XY48350
|
Ascorbic Acid
|
None
|
1 g
|
Effervescent Tablet (Passion Fruit Flavor)
|
Vitamin
|
Yue-Sheng Biotech Co., Ltd.
|
Taiwan
|
Initial (OTC)
|
20 September 2022
|
20 September 2027
|
| View |
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DR-XY48351
|
Oxycodone hydrochloride
|
Oxymarc
|
20 mg/2 mL
|
Solution for Injection/Infusion (I.V./S.C.)
|
Opioid Analgesic
|
HBM Pharma S.R.O.
|
Slovak Republic
|
Initial (Correction)
|
02 May 2023
|
06 October 2027
|
| View |
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DR-XY48352
|
Bisoprolol Fumarate
|
Bisodac 5
|
5mg
|
Film-Coated Tablet
|
Beta Blocking Agent
|
Aurobindo Pharma Limited
|
India
|
Initial
|
15 September 2022
|
15 September 2027
|
| View |
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DR-XY48353
|
Bisoprolol fumarate
|
Bisodac 10
|
10 mg
|
Film-Coated Tablet
|
Beta Blocking Agent
|
Aurobindo Pharma Limited
|
India
|
Initial
|
16 September 2022
|
16 September 2027
|
| View |
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DR-XY48354
|
Bisoprolol Fumarate
|
Bisodac 2.5
|
2.5mg
|
Film-Coated Tablet
|
Beta Blocking Agent
|
Aurobindo Pharma Limited
|
india
|
Initial
|
15 September 2022
|
15 September 2027
|
| View |
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DR-XY48355
|
Nicardipine Hydrochloride
|
Tensilo
|
1 mg/mL
|
Solution For Injection (I.V.)
|
Calcium Channel Blocker
|
PT. Pratapa Nirmala
|
Indonesia
|
Initial
|
29 September 2022
|
29 September 2027
|
| View |
DR-XY48356_PI_01.pdf
|
DR-XY48356
|
Solifenacin Succinate
|
Solifen
|
5mg
|
Film-Coated Tablet
|
Urological (Drugs for urinary frequency and incontinence)
|
Getz Pharma (Pvt.) Ltd.
|
Pakistan
|
Initial
|
15 September 2022
|
15 September 2027
|
| View |
DR-XY48357_PI_01.pdf
|
DR-XY48357
|
Solifenacin Succinate
|
Solifen
|
10mg
|
Film-Coated Tablet
|
Urological (Drugs for urinary frequency and
incontinence)
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
15 September 2022
|
15 September 2027
|
| View |
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DR-XY48358
|
Ascorbic Acid + Colecalciferol (Vitamin D3) + Zin
|
Tri-Protect
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate)/
1000 IU/ 10 mg (equivalent to 70.00 mg Zinc
Gluconate)
|
Capsule
|
Vitamins/Mineral
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
16 September 2022
|
16 September 2027
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| View |
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DR-XY48359
|
Biotin (Vitamin B7)
|
None
|
5 mg
|
Capsule
|
-
|
Solgar, Inc.
|
United States of America
|
Initial
|
16 September 2022
|
16 September 2027
|
| View |
|
DR-XY48360
|
Pregabalin
|
Prelica
|
150 mg
|
Capsule
|
Antiepileptic
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
Initial (Correction)
|
09 November 2022
|
19 September 2027
|
| View |
|
DR-XY48361
|
Pregabalin
|
Prelica
|
75 mg
|
Capsule
|
Antiepileptic
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
Initial (Correction)
|
09 November 2022
|
19 September 2027
|
| View |
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DR-XY48362
|
Nebivolol (as Hydrochloride)
|
Nevodio
|
5 mg
|
Tablet
|
Selective beta blocking agent
|
PT Dexa Medica
|
Indonesia
|
Monitored Release
|
19 September 2022
|
19 September 2027
|
| View |
|
DR-XY48363
|
Iron (as Ferric Hydroxide Sucrose Complex)
|
Eoferon
|
20 mg/mL (100 mg/5 mL)
|
Solution for Injection (IV)
|
-
|
Zee Laboratories Limited
|
India
|
Initial
|
05 October 2022
|
05 October 2027
|
| View |
|
DR-XY48364
|
Mecobalamin
|
None
|
500 mcg/mL
|
Solution for Injection (IM/IV)
|
Vitamin
|
Zee Laboratories Limited
|
India
|
Initial
|
28 September 2022
|
28 September 2027
|
| View |
DR-XY48365_PI_01.pdf
|
DR-XY48365
|
Tolvaptan
|
Jinarc
|
30mg
|
Tablet
|
Diuretic (Vasopressin Antagonist)
|
Otsuka Pharmaceutical Co., Ltd. (Tokushima Itano
Factory)
|
Japan
|
Monitored Release
|
20 September 2022
|
20 September 2027
|
| View |
|
DR-XY48366
|
Ketorolac Tromethamine
|
Kabirol
|
30 mg/mL
|
Solution for Injection (I.V./I.M.)
|
-
|
PT. Ethica Industri Farmasi (PT. Ethica)
|
Indonesia
|
Initial
|
20 September 2022
|
20 September 2027
|
| View |
|
DR-XY48367
|
Metformin hydrochloride + Sitagliptin (as phosphate)
|
Torsit M 1000
|
1 g/50 mg
|
Film-Coated Tablet
|
Blood glucose lowering drug
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
22 September 2022
|
22 September 2027
|