| View |
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DR-XY48918
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Tegafur Gimeracil Oteracil potassium
|
S-1 20
|
20 mg/5.8 mg/19.6 mg
|
Capsule
|
-
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Taiho Pharmaceutical Co., Ltd.
|
Japan
|
Monitored Release
|
15 November 2023
|
15 November 2028
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| View |
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DR-XY48919
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Cefuroxime (as sodium)
|
Feroxim
|
750 mg
|
Powder for Injection (IM/IV
|
-
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Vellinton Healthcare
|
India
|
Initial
|
16 November 2023
|
16 November 2028
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| View |
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DR-XY48920
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Cefuroxime (as sodium)
|
Meurox
|
1.5 g
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Powder for Injection (IM/IV)
|
-
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Vellinton Healthcare
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India
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Initial
|
16 November 2023
|
16 November 2028
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| View |
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DR-XY48921
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Benzydamine Hydrochloride + Chlorhexidine Digluconate
|
Solmux Throat
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1.5mg/1.2 mg per mL
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Oromucosal Spray
|
-
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Humanis Sağlık Anonim Şirketi
|
Turkey
|
nitial [OTC]
|
17 November 2023
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17 November 2028
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| View |
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DR-XY48922
|
Benzydamine Hydrochloride + Digluconate
|
Symptoblo
|
1.5mg/1.2 mg per mL
|
Oromucosal Spray
|
-
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Humanis Sağlık Anonim Şirketi
|
Turkey
|
Initial [OTC]
|
17 November 2023
|
17 November 2028
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| View |
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DR-XY48923
|
Benzydamine
Digluconate
Hydrochloride + Chlorhexidine
|
Swifteze
|
1.5 mg/1.2 mg per mL
|
Oromucosal Spray
|
-
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Humanis Sağlık Anonim Şirketi
|
Turkey
|
Initial [OTC]
|
17 November 2023
|
17 November 2028
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| View |
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DR-XY48924
|
Iron Zinc+ Folic acid
|
Feona FZ
|
48 mg (eq. to 350.784 mg Ferrous Ascorbate)/22.5 mg (eg. t (eq. to 61.80 mg Zinc Sulfate Monohydrate)/500 mcg
|
Film-Coated Tablet
|
-
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Delta Pharma Ltd.
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Bangladesh
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Initial
|
17 November 2023
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17 November 2028
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| View |
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DR-XY48925
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Ascorbic Acid + Zinc+ Cholecalciferol (Vitamiu D3)
|
Pure-Cee' ZD
|
500 mg (equivalent to 562.50 mg Sodium Ascorbate)/
15 mg
(equivalent to 41.18 mg
Monohydrate)/1000 IU
|
Capsule
|
-
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Growrich Manufacturing Inc.
|
Philippines
|
Initial
|
17 November 2023
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17 November 2028
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| View |
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DR-XY48926
|
Ascorbic Acid + Zinc
|
Optimus-Pro
|
500 mg (equivalent to 562.50 mg Sodium Ascorbate) 10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
-
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Compact Pharmaceuticals, Corp.
|
Philippines
|
Initial
|
22 November 2023
|
22 November 2028
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| View |
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DR-XY48927
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Paracetamol + Ibuprofen
|
AlaxanR Xtra (for BNC)
|
325 mg / 200 mg (equivalent to 256.23 mg Ibuprofen as
Sodium dihydrate)
|
Tablet
|
-
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UNILAB, Inc.
|
Philippines
|
Initial
|
22 November 2023
|
22 November 2028
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| View |
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DR-XY48928
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Memantine Hydrochloride
|
Alzhemed 20
|
20 mg
|
Film-Coated Tablet
|
-
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Unison Laboratories Co., Ltd.
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Thailand
|
Initial
|
22 November 2023
|
22 November 2028
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| View |
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DR-XY48929
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Entrectinib
|
Rozlytrek
|
100 mg
|
Capsule
|
-
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Mayne Pharma Inc.
|
USA
|
Monitored Release (Re-application)
|
23 November 2023
|
23 November 2028
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| View |
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DR-XY48930
|
Entrectinib nib
|
Rozlytrek
|
200 mg
|
Capsule
|
-
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Mayne Pharma Inc.
|
USA
|
Monitored Release (Re-application)
|
23 November 2023
|
22 November 2028
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| View |
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DR-XY48931
|
Pemetrexed (as disodium hemipentahydrate)
|
Pemtrex
|
10 mg/mL (500 mg/50 mL)
|
Solution for Injection
(IV Infusion)
|
-
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Shilpa Medicare Limited (Unit. 4, Pharmaceutical Formulations Sez)
|
India
|
Monitored Release (MR)
|
23 November 2023
|
23 November 2028
|
| View |
DR-XY48932_PI_01.pdf
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DR-XY48932
|
Cariprazine (as hydrochloride)
|
Reagila
|
6 mg
|
Capsule
|
-
|
Chemical Works of Gedeon Richter Plc.
|
Hungary
|
Monitored Release
|
24 November 2023
|
24 November 2028
|
| View |
DR-XY48933_PI_01.pdf
|
DR-XY48933
|
Cariprazine (as hydrochloride)
|
Reagila
|
4.5 mg
|
Capsule
|
-
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Chemical Works of Gedeon Richter
|
Hungary
|
Monitored Release
|
24 November 2023
|
24 November 2028
|
| View |
DR-XY48934_PI_01.pdf
|
DR-XY48934
|
Cariprazine (as hydrochloride)
|
Reagila
|
3 mg
|
Capsule
|
-
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Chemical Works of Gedeon Richter
|
Hungary
|
Monitored Release
|
24 November 2023
|
24 November 2028
|
| View |
DR-XY48935_PI_01.pdf
|
DR-XY48935
|
Cariprazine (as hydrochloride)
|
Reagila
|
1.5 mg
|
Capsule
|
-
|
Chemical Works of Gedeon Richter
|
Hungary
|
Monitored Release
|
24 November 2023
|
24 November 2028
|
| View |
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DR-XY48936
|
Doripenem (as monohydrate)
|
None
|
500 mg
|
Powder for Injection (I.V.)
|
-
|
Shamshree Lifesciences Ltd.
|
India
|
Initial
|
29 November 2023
|
29 November 2028
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| View |
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DR-XY48937
|
Multivitamins + Minerals
|
Berocca Energy
|
Each Effervescent Tablet contains:
Ascorbic Acid (Vitamin C)
500mg
Riboflavin (Vitamin B.)
15mg
Calcium (as calcium carbonate and calcium pantothenate)
100mg
Pyridoxine hydrochloride (Vitamin B)
10mg
Magnesium (as magnesium carbonate and magnesium sulfate dihydrate) 100mg
Zinc (as zinc citrate trihydrate)
10mg
400mcg
Nicotinamide (Vitamin B1)
50mg
Folic acid
150mcg
Pantothenic acid (Vitamin B1)
23mg
Biotin (Vitamin H)
Thiamine hydrochloride (Vitamin B1)
15mg
Cyanocobalamin (Vitamin B12)
10mcg
3 mm
84 mm
4.5 mm
11 mm
|
Effervescent Tablet
|
Vitamins / Minerals
|
PT. Bayer Indonesia
|
Indonesia
|
Initial (Correction)
|
02 April 2024
|
29 November 2028
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