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DR-XY48528
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Ascorbic Acid + Zinc
|
Revitazee
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate)/ 40mg
(equivalent to 110 mg Zinc
Monohydrate)
|
Capsule
|
-
|
Compact Pharmaceuticals, Corp.
|
Philippines
|
Initial (OTC)
|
14 December 2022
|
14 December 2027
|
| View |
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DR-XY48529
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Olmesartan Medoxomil + Amlodipine (as Besilate)
|
Alzor CCB
|
40mg/5mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial (Correction)
|
23 January 2023
|
14 December 2025
|
| View |
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DR-XY4853
|
Urea
|
Nutraplus
|
100mg/mL
|
Lotion
|
Emollient
|
Hizon Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
24 September 2020
|
21 September 2025
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| View |
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DR-XY48530
|
Sitagliptin (as phosphate monohydrate)
|
Sitavia 50
|
50 mg
|
Film-Coated Tablet
|
-
|
Korea United Pharm., Int'l Jsc.
|
Vietnam
|
Initial
|
14 December 2022
|
14 December 2027
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| View |
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DR-XY48531
|
Sitagliptin (as phosphate monohydrate)
|
Sitavia 100
|
100 mg
|
Film-Coated Tablet
|
-
|
Korea United Pharm., Int'l Jsc.
|
Vietnam
|
Initial
|
14 December 2022
|
14 December 2027
|
| View |
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DR-XY48532
|
Fentanyl (as citrate)
|
Fentamar
|
50 mcg/mL (100 mcg/2 mL)
|
Solution For Injection (I.M./I.V.)
|
-
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HBM Pharma S.R.O.
|
Slovak Republic
|
Initial [Correction]
|
02 March 2023
|
16 December 2027
|
| View |
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DR-XY48533
|
Ascorbic Acid + Colecalciferol (Vitamin D3) + Zinc
|
None
|
500 mg (equivalent to 562.4 mg Sodium Ascorbate)/200 IU/4 mg (equivalent to 28 mg Zinc Gluconate)
|
Capsule
|
-
|
GMP Laboratories of America, Inc.
|
United States of America
|
Initial [OTC](Reapplication)
|
23 December 2022
|
23 December 2027
|
| View |
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DR-XY48534
|
Guaifenesin
|
Guafensin
|
100 mg/5 mL
|
Syrup (Peach Flavor)
|
-
|
Y.S.P Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial [OTC]
|
22 December 2022
|
22 December 2027
|
| View |
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DR-XY48535
|
Ascorbic Acid
|
Swiss Energy by Dr. Frei
|
1000 mg
|
Effervescent Tablet
|
-
|
Alpex Pharma SA
|
Switzerland
|
Initial [OTC] (Reapplication)
|
27 December 2022
|
27 December 2027
|
| View |
DR-XY48536_PI_01.pdf
|
DR-XY48536
|
Fosaprepitant (as Dimeglumine)
|
Fosap
|
150 mg
|
Lyophilized Powder for Solution for IV Infusion
|
-
|
Aspiro Pharma Limited
|
India
|
Monitored Release (Correction)
|
02 February 2023
|
22 December 2027
|
| View |
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DR-XY48537
|
Anastrozole
|
Fobrecane
|
1 mg
|
Film-Coated Tablet
|
-
|
Bruck Pharma Private Limited
|
India
|
Initial
|
22 December 2022
|
22 December 2027
|
| View |
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DR-XY48538
|
Montelukast (as sodium) + Levocetirizine hydrochloride
|
None
|
10 mg/ 5 mg
|
Film Coated Tablet
|
-
|
Cadila Healthcare Limited
|
India
|
Initial
|
23 December 2022
|
23 December 2027
|
| View |
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DR-XY48540
|
Sildenafil (as citrate)
|
Onagra-100
|
100 mg
|
Film Coated Tablet
|
-
|
Sai Mirra Innopharm Pvt. Ltd.
|
India
|
Initial
|
27 December 2022
|
27 December 2027
|
| View |
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DR-XY48541
|
Doxofylline
|
Maxivent
|
200mg
|
Tablet
|
Bronchodilator
|
Ajanta Pharma Limited
|
India
|
Initial
|
28 December 2022
|
28 December 2027
|
| View |
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DR-XY48542
|
Sitagliptin (as phosphate monohydrate)
|
Sitamac 25
|
25 mg
|
Film-Coated Tablet
|
-
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
03 January 2023
|
03 January 2028
|
| View |
|
DR-XY48543
|
Sitagliptin (as phosphate monohydrate)
|
Sitamac 50
|
50 mg
|
Film-Coated Tablet
|
-
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
03 January 2023
|
03 January 2028
|
| View |
|
DR-XY48544
|
Sitagliptin (as phosphate monohydrate)
|
Sitamac 100
|
100 mg
|
Film-Coated Tablet
|
-
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
03 January 2023
|
03 January 2028
|
| View |
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DR-XY48545
|
Quetiapine (As Fumarate)
|
Victus XR
|
50 mg
|
Sustained Release Tablet
|
-
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
29 December 2022
|
29 December 2027
|
| View |
DR-XY48546_PI_01.pdf
|
DR-XY48546
|
Sitagliptin (As Hydrochloride)
|
Sitazit 100
|
100 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited, Unit V
|
India
|
Monitored Release
|
29 December 2022
|
29 December 2027
|
| View |
DR-XY48547_PI_01.pdf
|
DR-XY48547
|
Sitagliptin (As Hydrochloride)
|
Sitazit 25
|
25 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited, Unit V
|
India
|
Monitored Release
|
29 December 2022
|
29 December 2027
|