| View |
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DR-XY47931
|
Ketoconazole + Clobetasol Propionate
|
None
|
10 mg/ 500 mcg per gram
|
Cream
|
Antifungal / Corticosteroid
|
Front Pharmaceutical PLC
|
China
|
Initial
|
12 April 2022
|
12 April 2027
|
| View |
|
DR-XY47932
|
Manganese
|
None
|
8mg (equivalent to 57.5mg Manganese Glycinate
Amino Acid Chelate)
|
Tablet
|
Mineral
|
Solgar, Inc.
|
United States of America
|
Initial
|
18 April 2022
|
18 April 2026
|
| View |
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DR-XY47933
|
Omeprazole (As Sodium)
|
None
|
20 mg
|
Lyophilized Powder for Intravenous Injection/ Infusion
|
Proton Pump Inhibitor
|
Shandong Yuxin Pharmaceutical Co., Ltd.
|
China
|
-
|
25 April 2022
|
25 April 2027
|
| View |
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DR-XY47934
|
Glutathione
|
Staluta 600
|
600mg
|
Lyophilization Powder For Injection (IM/IV)
|
Antidotes
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
13 April 2022
|
13 April 2027
|
| View |
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DR-XY47935
|
Ranolazine
|
Razine
|
1 g
|
Extended-Release Tablet
|
Anti-Angina
|
Ajanta Pharma Limited
|
India
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
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DR-XY47936
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Ranolazine
|
Razine
|
375 mg
|
Extended-Release Tablet
|
Anti-Angina
|
Ajanta Pharma Limited
|
India
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
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DR-XY47937
|
Omeprazole (As Sodium)
|
None
|
40 mg
|
Lyophilized Powder for Intravenous Injection/ Infusion
|
Proton Pump Inhibitor
|
Shandong Yuxin Pharmaceutical Co., Ltd.
|
China
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
DR-XY47938_PI_01.pdf
|
DR-XY47938
|
Menthol + Glycyrrhiza glabra (Liquorice) Root +
Zingiber officinale (Ginger) Rhizome + Phyllantus
emblica (Indian Gooseberry) Fruit
|
Vicks VapoDrops
|
7 mg/ 15mg/ 10 mg/ 10 mg
|
Lozenge (Orange Menthol
Flavor)
|
Throat Preparation
|
Unique Pharmaceutical Laboratories (Division of J.B.
Chemicals & Pharmaceuticals Ltd.)
|
India
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
|
DR-XY47939
|
Menthol + Glycyrrhiza glabra (Liquorice) Root +
Zingiber officinale (Ginger) Rhizome + Phyllantus
emblica (Indian Gooseberry) Fruit
|
Vicks VapoDrops
|
7 mg/ 15mg/ 10 mg/ 10 mg
|
Lozenge (Honey Lemon
Menthol Flavor)
|
Throat Preparation
|
Unique Pharmaceutical Laboratories (Division of J.B.
Chemicals & Pharmaceuticals Ltd.)
|
India
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
|
DR-XY47940
|
Menthol + Glycyrrhiza glabra (Liquorice) Root +
Zingiber officinale (Ginger) Rhizome + Phyllantus
emblica (Indian Gooseberry) Fruit
|
Vicks VapoDrops
|
7 mg/ 15mg/ 10 mg/ 10 mg
|
Lozenge (Berry Menthol
Flavor)
|
Throat Preparation
|
Unique Pharmaceutical Laboratories (Division of J.B.
Chemicals & Pharmaceuticals Ltd.)
|
India
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
|
DR-XY47941
|
Cholecalciferol (Vitamin D3)
|
None
|
10mcg (400IU)
|
Softgel Capsule
|
Vitamin
|
Nexgen Pharma, Inc.
|
United States of America
|
Initial
|
18 April 2022
|
18 April 2025
|
| View |
DR-XY47942_PI_01.pdf
|
DR-XY47942
|
Daclatasvir (as dihydrochloride)
|
Virdac 30
|
30 mg
|
Film-Coated Tablet
|
Antiviral
|
Hetero Labs Limited (Unit V)
|
India
|
Monitored Release
|
18 April 2022
|
18 April 2027
|
| View |
DR-XY47943_PI_01.pdf
|
DR-XY47943
|
Daclatasvir (as dihydrochloride)
|
Virdac 60
|
60 mg
|
Film-Coated Tablet
|
Antiviral
|
Hetero Labs Limited (Unit V)
|
India
|
Monitored Release
|
18 April 2022
|
18 April 2027
|
| View |
|
DR-XY47944
|
Silodosin
|
Ureleve
|
2mg
|
Capsule
|
Alpha-Adrenoreceptor Antagonist
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
19 April 2022
|
19 April 2027
|
| View |
DR-XY47945_PI_01.pdf
|
DR-XY47945
|
Bendamustine Hydrochloride (as monohydrate)
|
Bentero 25
|
25 mg
|
Lyophilized Powder for Concentrate for
Solution for I.V. Infusion
|
Antineoplastic Agent (Nitrogen Mustard Analogue)
|
Hetero Labs Limited (Unit-VI)
|
India
|
Monitored Release (CPR Correction)
|
19 August 2022
|
19 April 2025
|
| View |
|
DR-XY47946
|
Povidone-Iodine
|
Betamed
|
10% w/v
|
Solution
|
Antiseptic
|
The Medicpharma Co., Ltd.
|
Thailand
|
Initial
|
19 April 2022
|
19 April 2027
|
| View |
DR-XY47947_PI_01.pdf
|
DR-XY47947
|
Gemcitabine
|
Gemcilex
|
1 g
|
Powder for Injection (IV)
|
Antineoplastic (Pyrimidine analogues)
|
Laboratorio Kemex S.A.
|
Argentine Republic
|
Initial
|
20 April 2022
|
20 April 2027
|
| View |
|
DR-XY47948
|
D-Alpha Tocopherol
(Vitamin E)
|
Fern-E
|
400 I.U.
|
Softgel Capsule
|
Vitamin
|
Hizon Laboratories, Inc.
|
Philippines
|
Initial
|
20 April 2022
|
20 April 2027
|
| View |
|
DR-XY47949
|
Omeprazole
|
Ml-Gacid
|
20 mg
|
Delayed-Release Capsule
|
Proton Pump Inhibitor
|
Milan Laboratories Private Limited
|
India
|
Initial
|
20 April 2022
|
20 April 2027
|
| View |
|
DR-XY47950
|
Azacitidine
|
Maturus
|
100 mg
|
Lyophilized Powder for Injection (S.C./1.V.)
|
Antineoplastic (Pyrimidine analogues)
|
Laboratorio Kemex S.A.
|
Argentina
|
Monitored Release
|
20 April 2022
|
20 April 2027
|