| View |
DR-XY48106_PI_01.pdf
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DR-XY48106
|
Rosuvastatin (as calcium) & Ezetimibe
|
Lypstaplus
|
20 mg/10 mg
|
film coated tablet
|
-
|
Medreich Limited (Unit 3)
|
India
|
Monitored Release
|
14 June 2022
|
14 June 2027
|
| View |
DR-XY48107_PI_01.pdf
|
DR-XY48107
|
Rosuvastatin (as calcium) & Ezetimibe
|
Lypstaplus
|
10 mg/10 mg
|
film coated tablet
|
-
|
Medreich Limited (Unit 3)
|
India
|
Monitored Release
|
14 June 2022
|
14 June 2027
|
| View |
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DR-XY48080
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Hydroxychloroquine Sulfate
|
HCQS
|
200 mg
|
Film-Coated Tablet
|
Antimalarial/Antirheumatic
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Ipca Laboratories Limited
|
India
|
Initial
|
02 June 2022
|
02 June 2027
|
| View |
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DR-XY48082
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Pramipexole dihydrochloride monohydrate
|
Piritan
|
1 mg
|
Tablet
|
Antiparkinson drug (Dopamine Agonist)
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial [Correction]
|
08 April 2024
|
06 June 2027
|
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DRP-12023
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Aurotazevan
|
4 g/500 mg
|
Powder for Injection (I.V.)
|
Antibacterial (Penicillin-Beta-Lactamase Inhibitor
Combination)
|
Aurobindo Pharma Limited (Unit XII)
|
India
|
Initial
|
30 May 2022
|
30 May 2027
|
| View |
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DR-XY40427
|
Dinoprostone
|
Propess
|
10 mg
|
Modified-Release Vaginal Suppository
|
Oxytocic
|
Ferring Controlled Therapeutics Limited
|
United Kingdom
|
Renewal
|
04 August 2024
|
19 December 2029
|
| View |
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DR-XY48081
|
Ceftriaxone (As Sodium)
|
None
|
1 g
|
Powder For Injection (IM/IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
02 June 2022
|
02 June 2027
|
| View |
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DR-XY48079
|
Solifenacin succinate
|
Abo 10
|
10 mg
|
Film-Coated Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
01 June 2022
|
01 June 2027
|
| View |
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DRP-12126
|
Glipizide
|
Diglip 10
|
10 mg
|
Extended Release Tablet
|
Blood Glucose Lowering Drug (Sulfonylurea)
|
Unique Pharmaceuticals Laboratories (A Division of
J.B. Chemicals & Pharmaceuticals Ltd.)
|
India
|
Initial (correction)
|
26 January 2023
|
17 June 2027
|
| View |
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DRP-12125
|
Glipizide
|
Diglip 5
|
5 mg
|
Extended Release Tablet
|
Blood Glucose Lowering Drug (Sulfonylurea)
|
Unique Pharmaceuticals Laboratories (A Division of
J.B. Chemicals & Pharmaceuticals Ltd.)
|
India
|
Initial
|
17 June 2022
|
17 June 2027
|
| View |
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DRP-12091
|
Paracetamol
|
Xfebril
|
10 mg/mL (1g/100 mL)
|
Solution for I.V. Infusion
|
Analgesic/Antipyretic
|
Centurion İlaç Sanayi ve Ticaret A.Ş.
|
Turkey
|
Initial
|
10 June 2022
|
10 June 2027
|
| View |
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DR-XY48113
|
Iron (As Iron Sucrose)
|
Ranofer
|
20 mg/mL (100mg/5 mL)
|
Solution for Injection (I.V.)
|
Antianemic preparation
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
17 June 2022
|
17 June 2027
|
| View |
|
DR-XY 48101
|
Vancomycin Hydrochloride
|
Vancover
|
125 mg
|
Capsule
|
Antibacterial (Glycopepure
|
Orient Pharma Co., Ltd.
|
Taiwan
|
Monitored Release
|
09 June 2022
|
09 June 2025
|
| View |
|
DR-XY48100
|
Vancomycin (as hydrochloride)
|
Vancover
|
250 mg
|
Capsule
|
Antibacterial (Glycopeptide)
|
Orient Pharma Co., Ltd.
|
Taiwan
|
Monitored Release
|
09 June 2022
|
09 June 2025
|
| View |
|
BRP-108
|
Pegfilgrastim
|
Pelgraz
|
6mg/0.6mL
|
Solution For Injection (SC)
|
-
|
Intas Pharmaceuticals Ltd. (Biopharma Division)
|
India
|
Initial
|
07 June 2022
|
07 June 2027
|
| View |
|
DR-XY48095
|
Peritoneal Dialysis with 1.5% Dextrose
|
None
|
Each 100 mL contains: Dextrose.... 1.5 g Sodium chloride.... 538 mg
Magnesium chloride hexahydrate .... 5.1 mg
Sodium lactate......448 mg Calcium chloride dihydrate....26 mg
|
Dialysis Solution for Intraperitoneal
|
Peritoneal Dialytics
|
Shijiazhuang No. 4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
08 June 2022
|
08 June 2027
|
| View |
|
DRP-12072
|
Meropenem (As trihydrate)
|
Merosaph 500
|
500 mg
|
Powder For Injection (I.V)
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
07 June 2022
|
07 June 2027
|
| View |
|
DRP-12071
|
Meropenem (As trihydrate)
|
Merosaph 1000
|
1g
|
Powder For Injection (I.V)
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
07 June 2022
|
07 June 2027
|
| View |
|
DRP-12123
|
Decitabine
|
Decima
|
50 mg
|
Lyophilized Powder for Injection (I.V.)
|
Antineoplastic Agent (Pyrimidine Analogue)
|
Jari Pharmaceutical Co., Ltd.
|
China
|
Initial
|
16 June 2022
|
16 June 2027
|
| View |
|
DR-XY48111
|
Rasagiline (as tartrate)
|
None
|
1 mg
|
Tablet
|
Dopaminergic Agent (Monoamine Oxidase B Inhibitor)
|
Lacer, S.A.
|
Spain
|
Initial
|
16 June 2022
|
16 June 2027
|