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DR-XY44365_PI_01.pdf
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DR-XY44365
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Lauromacrogol 400 + Hydrocortisone Acetate
|
Korto-S
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27 mg / 5 mg
|
Rectal Suppository
|
-
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Exeltis Ilac San. Ve Tic. A.S.
|
Turkey
|
Initial (from Monitored Release)
|
25 April 2023
|
08 February 2028
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DR-XY44366
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Cefuroxime (As Sodium)
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Cefurone
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750 mg
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Powder For Injection (Im/Iv)
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-
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Kyongbo Pharmaceutical Co., Ltd.
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Korea
|
-
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21 January 2020
|
25 March 2025
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DR-XY44376
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Olanzapine
|
Olanza 5
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5 mg
|
Film-Coated Tablet
|
-
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Unison Laboratories Co., Ltd.
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Thailand
|
-
|
13 April 2020
|
07 April 2025
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| View |
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DR-XY44377
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Tramadol hydrochloride + Paracetamol
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Tramadin Plus
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37.5mg/325mg
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Film-Coated Tablet
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Analgesic/Antipyretic
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Korea Pharma Co., Ltd.
|
Korea
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Renewal
|
27 October 2024
|
07 April 2030
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DR-XY44386
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Enalapril Maleate
|
Naprilate
|
5mg
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Tablet
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ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITOR
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Taiwan Biotech Co., Ltd.
|
Taiwan
|
Automatic Renewal
|
01 April 2022
|
30 March 2027
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DR-XY44387
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Enalapril Maleate
|
Naprilate
|
20 mg
|
Tablet
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ACE INHIBITOR
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Taiwan Biotech Co., Ltd.
|
Taiwan
|
Renewal
|
20 May 2022
|
30 March 2027
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| View |
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DR-XY44396
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Bupivacaine Hydrochloride In Dextrose
|
Regivell
|
5mg/mL (0.5%w/v)
|
Solution For Injection (Spinal)
|
-
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PT Novell Pharmaceutical Laboratories
|
Indonesia
|
Automatic Renewal (Reconstruction)
|
16 January 2024
|
13 April 2025
|
| View |
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DR-XY44397
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Ofloxacin
|
Ofloxen
|
3mg/Ml (0.3%w/v)
|
Ophthalmic Solution (Eye Drops)
|
-
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Cisen Pharmaceutical Co., Ltd
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China
|
-
|
21 April 2020
|
16 April 2025
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| View |
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DR-XY44401
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Azithromycin (as dihydrate)
|
Rozitan
|
200mg/ 5mL
|
Powder for Suspension
|
Antibacterial
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Fredun Pharmaceuticals Ltd.
|
India
|
Automatic Renewal
|
24 December 2021
|
07 April 2027
|
| View |
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DR-XY44407
|
Metoprolol Tartrate
|
Meto-L
|
50 mg
|
Film- Coated Tablet
|
-
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Lloyd Laboratories, Inc.
|
Philippines
|
-
|
31 March 2020
|
07 April 2025
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| View |
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DR-XY44409
|
Diclofenac Diethylamine
|
Dici-Gel
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11.6 mg/g (1.16% w/w)
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Topical Gel
|
-
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Lloyd Laboratories, Inc.
|
Philippines
|
-
|
06 October 2020
|
07 April 2025
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| View |
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DR-XY44410
|
Perampanel
|
Fycompa
|
8mg
|
Film-Coated Tablet
|
Antiepileptic
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Eisai Manufacturing Limited
|
United Kingdom
|
Renewal
|
10 May 2024
|
31 March 2030
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| View |
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DR-XY44424
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Atosiban (As Acetate)
|
Evaban
|
7.5 mg/mL (6.75 mg/0.9 mL)
|
Solution for IV Injection
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Tocolytic
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Norris Medicines Limited
|
India
|
Initial [from Monitored Release]
|
24 November 2022
|
06 October 2025
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| View |
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DR-XY44426
|
QUETIAPINE (as fumarate)
|
Alvoquel
|
100 mg
|
Film coated tablet
|
-
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Genepharm S.A.
|
Greece
|
-
|
14 September 2020
|
16 April 2025
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| View |
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DR-XY44427
|
QUETIAPINE (as fumarate)
|
Alvoquel
|
25 mg
|
Film coated Tablet
|
-
|
Genepharm S.A.
|
Greece
|
-
|
14 September 2020
|
16 April 2025
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| View |
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DR-XY44432
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Amlodipine (As Besilate)
|
None
|
10 mg
|
Film-Coated Tablet
|
-
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Lloyd Laboratories, Inc.
|
Philippines
|
-
|
06 October 2020
|
15 April 2025
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| View |
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DR-XY44433
|
Fexofenadine Hydrochloride
|
Xafen 120
|
120 mg
|
Film-Coated Tablet
|
-
|
Medreich Limited (Unit 3)
|
India
|
-
|
21 July 2020
|
20 August 2025
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| View |
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DR-XY44435
|
Celecoxib
|
Zelecta
|
400 mg
|
Capsule
|
-
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Lloyd Laboratories, Inc.
|
Philippines
|
-
|
24 April 2020
|
28 April 2025
|
| View |
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DR-XY44437
|
Olopatadine (As Hydrochloride)
|
Avicon
|
1mg/mL (0.01% w/v)
|
Ophthalmic Solution
|
-
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The ACME Laboratories Ltd.
|
Bangladesh
|
-
|
13 February 2020
|
16 April 2025
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| View |
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DR-XY44439
|
Celecoxib
|
Zelecta
|
200 mg
|
Capsule
|
-
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Lloyd Laboratories, Inc.
|
Philippines
|
-
|
24 April 2020
|
28 April 2025
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