| View |
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DR-XY48938
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Multivitamins + Minerals
|
Berocca Energy
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Each Effervescent Tablet contains:
15mg
500mg
Riboflavin (Vitamin B2)
Ascorbic Acid (Vitamin C)
Calcium (as calcium carbonate and calcium pantothenate)
100mg
Pyridoxine hydrochloride (Vitamin B)
10mg
10my
Magnesium (as magnesium carbonate and magnesium sulfate dihydrate) 100mg
Zinc (as zinc citrate trihydrate)
50mg
Nicotinamide (Vitamin B1)
23mg
Pantothenic acid (Vitamin B5)
Thiamine hydrochloride (Vitamin B1)
15mg
Folic acid
Biotin (Vitamin H)
Cyanocobalamin (Vitamin B1:)
400mcg
150mcg
10mcg
3 mm
119 mm
4.5 mm
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Effervescent Tablet
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-
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PT. Bayer Indonesia
|
Indonesia
|
Initial
|
29 November 2023
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29 November 2028
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| View |
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DR-XY48939
|
Multivitamins + Minerals
|
Berocca Energy
|
Each Effervescent Tablet contains:
Ascorbic Acid (Vitamin C)
500mg
Riboflavin (Vitamin B2)
15mg
Calcium (as calcium carbonate and calcium pantothenate)
100mg
Pyridoxine hydrochloride (Vitamin B1)
10mg
Magnesium (as magnesium carbonate and magnesium sulfate dihydrate) 100mg
Zinc (as zinc citrate trihydrate)
10mg
400mcg
Nicotinamide (Vitamin B1)
50mg
Folic acid
Pantothenic acid (Vitamin Bs)
23mg
Biotin (Vitamin H)
150mcg
Thiamine hydrochloride (Vitamin B1)
15mg
Cyanocobalamin (Vitamin B12)
10mcg
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Effervescent Tablet (Mango Flavor)
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Vitamins Minerals
|
PT. Bayer Indonesia
|
Indonesia
|
Initial (Correction)
|
02 April 2024
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29 November 2028
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| View |
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DR-XY48940
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Paracetamol
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Tempra Blizz
|
500 mg
|
Granules for Solution (Orange Flavor)
|
-
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DHG Pharmaceutical Joint-Stock Company
|
Vietnam
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Initial [OTC]
|
29 November 2023
|
29 November 2028
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| View |
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DR-XY48941
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Telmisartan
|
Telatraz
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80 mg
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Tablet
|
-
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Alembic Pharmaceuticals Limited
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India
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Initial
|
29 November 2023
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29 November 2028
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| View |
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DR-XY48943
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Azithromycin (as dihydrate)
|
Aeromycin - 500
|
500mg
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Film - Coated Tablet
|
-
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CSPC Ouyi Pharmaceutical Co., Ltd.
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China
|
Initial
|
30 November 2023
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30 November 2028
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| View |
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DR-XY48944
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Acetylcysteine
|
Fluimucil
|
600 mg
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Granules for Oral Solution
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Mucolytic
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Zambon Switzerland Ltd.
|
Switzerland
|
Initial (Correction)
|
26 July 2024
|
04 December 2028
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| View |
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DR-XY48945
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Dapagliflozin
|
Invaflozin 10
|
10mg
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Film-Coated Tablet
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-
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Inventia Healthcare Limited
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India
|
Initial
|
14 December 2023
|
14 December 2028
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| View |
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DR-XY48947
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Gliclazide
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Diakon MR
|
60 mg
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Modified-Release Tablet
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-
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Magbro Healthcare Pvt. Ltd.
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India
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Initial
|
20 December 2023
|
20 December 2028
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| View |
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DR-XY48948
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Ceftazidime
|
None
|
1 g
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Powder for Injection (IM/IV)
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-
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Vellinton Healthcare
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India
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Initial
|
20 December 2023
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20 December 2028
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| View |
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DR-XY48949
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Ceftriaxone (as sodium)
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None
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1 g
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Powder for Injection (IV)
|
-
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Reyoung Pharmaceutical Co., Ltd.
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China
|
Initial
|
20 December 2023
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20 December 2028
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| View |
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DR-XY48950
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Ceftriaxone (as sodium)
|
None
|
2 g
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Powder For Injection (IM/IV)
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-
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Vellinton Healthcare
|
India
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Initial
|
20 December 2023
|
20 December 2028
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| View |
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DR-XY48951
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Paracetamol + Ibuprofen (as sodium dihydrate)
|
Fasrel
|
325 mg / 200 mg
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Tablet
|
-
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UNILAB, Inc.
|
Philippines
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Initial
:
|
28 December 2023
|
28 December 2028
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| View |
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DR-XY48952
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Ibuprofen
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None
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400 mg
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Softgel Capsule
|
-
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Softgel Healthcare Pvt. Ltd.
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Singapore
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Initial |OTC]
|
21 December 2023
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21 December 2025
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| View |
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DR-XY48953
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Ferrous sulfate + Folic acid
|
None
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200 mg (equivalent to 60 mg elemental Iron) 400 mcg
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Film-Coated Tablet
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Anti-Anemic
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Medicamen Organics Limited (Unit 1)
|
India
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Initial
|
11 January 2024
|
11 January 2029
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| View |
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DR-XY48954
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Olmesartan medoxomil
|
Olmespec 40
|
40mg
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Film - Coated Tablet
|
-
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Aurobindo Pharma Limited Unit VII
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India
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Initial
|
21 December 2023
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21 December 2028
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| View |
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DR-XY48955
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Olmesartan Medoxomil
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Olmespec 20
|
20 mg
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Film - Coated Tablet
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Angiotensin II Receptor Blocker (ARB)
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Aurobindo Pharma Limited Unit VII
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India
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Initial
|
21 December 2023
|
21 December 2028
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| View |
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DR-XY48956
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Amlodipine (as besilate)
|
Khrizdipine 10
|
10 mg
|
Tablet
|
Anti-Hypertensive And Anti-Anginal Agent
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Celogen Generics Private Ltd.
|
India
|
Initial
|
22 December 2023
|
22 December 2028
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| View |
DR-XY48957_PI_01.pdf
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DR-XY48957
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Doxylamine Succinate + Pyridoxine Hydrochloride
|
Diclegis
|
10mg/10mg
|
Delayed-Release Tablet
|
Antihistamine (Aminoalkyl ether)
|
Duchesnay Inc.
|
Canada
|
Monitored Release
|
22 December 2023
|
22 December 2028
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| View |
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DR-XY48958
|
Eslicarbazepine (as acetate)
|
Excarb 200
|
200 mg
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Tablet
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Antiepileptic
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TORRENT PHARMACEUTICALS LTD.
|
India
|
Monitored Release
|
22 December 2023
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22 December 2028
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| View |
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DR-XY48959
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Eslicarbazepine (as acetate)
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Excarb 400
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400 mg
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Tablet
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Antiepileptic (Carboxamide Derivative)
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TORRENT PHARMACEUTICALS LTD.
|
India
|
Monitored Release
|
22 December 2023
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22 December 2028
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