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DRP-11689_PI_01.pdf
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DRP-11689
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Flourouracil
|
Fluoracilex
|
50 mg/mL (500 mg/10 mL)
|
Solution for I.V.
Injection/Infusion
|
Antineoplastic Agent (Pyrimidine Analogue)
|
Laboratorio Kemex S.A.
|
Argentine Republic
|
Initial
|
13 April 2022
|
13 April 2027
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DR-XY47953
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Levetiracetam
|
Epilept
|
500mg/5mL
|
Concentrate For Solution For Infusion
|
Gynecological Anti-infective and Antiseptic
|
Maiva Pharma Pvt. Ltd.
|
India
|
Initial
|
21 April 2022
|
21 April 2027
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DRP-11688
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Cefoperazone (as sodium) + Sulbactam (as sodium)
|
Efozone-S
|
1 g
|
Powder for Injection (I.M./1.V.)
|
Antibacterial (Cephalosporin-Beta-Lactamase Inhibitor Combination)
|
NCPC Hebei Huamin Pharmaceutical Co., Limited
|
China
|
Initial
|
13 April 2022
|
13 April 2027
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DRP-11696
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Celecoxib
|
Celevid
|
200mg
|
Capsule
|
Anti-inflammatory and Anti-rheumatoid product, Nonsteroids (NSAID)
|
Hovid Bhd.
|
Malaysia
|
Initial
|
21 April 2022
|
21 April 2027
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DR-XY 41031
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Levobupivacaine (As Hydrochloride)
|
Chirocaine
|
5 mg/mL
|
Solution for Injection (Epidural, Intrathecal,
Peripheral, Local Infiltration and Peribulbar Block)
|
-
|
Curida AS
|
Norway
|
-
|
20 April 2022
|
05 July 2025
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DRP-11693
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Cephalexin
|
None
|
500 mg
|
Capsule
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First Generation Cephalosporins
|
Lifesquare Laboratories Inc,
|
Philippines
|
Initial
|
20 April 2022
|
20 April 2027
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DRP-11703
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Budesonide
|
Budaxin 200
|
200 mcg
|
Dry Powder for Inhalation
|
Glucocorticoids
|
Mepro Pharmaceuticals Private Limited
|
India
|
Initial
|
19 April 2022
|
19 April 2027
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| View |
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DR-XY47918
|
Docetaxel (as Trihydrate)
|
Admoxel-120
|
120mg/3mL
|
Concentrate Solution for IV Infusion
|
Antineoplastic
|
Admac Lifesciences
|
India
|
Initial
|
08 April 2022
|
08 April 2027
|
| View |
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DR-XY47920
|
Docetaxel (as Trihydrate)
|
Admoxel- 80
|
80mg/2mL
|
Concentrate Solution for IV Infusion
|
-
|
Admac Lifesciences
|
India
|
-
|
08 April 2022
|
08 April 2027
|
| View |
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DR-XY47919
|
Docetaxel (as Trihydrate)
|
Admoxel- 20
|
20mg/0.5mL
|
Concentrate Solution for IV Infusion
|
Antineoplastic
|
Admac Lifesciences
|
India
|
Initial
|
08 April 2022
|
08 April 2027
|
| View |
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DR-XY47941
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Cholecalciferol (Vitamin D3)
|
None
|
10mcg (400IU)
|
Softgel Capsule
|
Vitamin
|
Nexgen Pharma, Inc.
|
United States of America
|
Initial
|
18 April 2022
|
18 April 2025
|
| View |
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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-XY47852
|
Methylprednisolone Sodium Succinate
|
Succimed
|
1 g
|
Powder For Injection (IV/IM)
|
Corticosteroid
|
VHB Medi Sciences Limited
|
India
|
Initial [Rx](Correction)
|
10 August 2022
|
30 March 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
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| View |
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DRP-11691
|
Montelukast (as sodium) + Levocetirizine hydrochloride
|
Xerin
|
10 mg/5 mg
|
Film coated tablet
|
-
|
Akums Drugs & Pharmaceuticals Ltd. (Plant 1 - Solid
Oral Dosage Facility)
|
India
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
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DRP-11690
|
Hyoscine Butylbromide
|
Hyozani
|
20 mg/mL
|
Solution for Injection (I.M./I.V./S.C.)
|
Antispasmodic
|
Makcur Laboratories Limited
|
India
|
Initial
|
19 April 2022
|
19 April 2027
|
| View |
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DRP-11669
|
Esomeprazole Magnesium
|
Ezoprole
|
20 mg
|
Delayed-Release Capsule
|
-
|
KRKA, D.D., Novo Mesto
|
Slovenia
|
-
|
11 April 2022
|
11 April 2027
|
| View |
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DR-XY47917
|
Acetylcysteine
|
Flumistin
|
200 mg
|
Powder For Oral Solution
|
Mucolytic
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
08 April 2022
|
08 April 2027
|
| View |
|
DRP-11716
|
Paclitaxel
|
Taxitas-30
|
6 mg/mL (30 mg/5 mL)
|
Concentrate for Solution for Infusion
|
Antineoplastic (Taxane)
|
ADMAC Lifesciences
|
India
|
Initial
|
21 April 2022
|
21 April 2027
|
| View |
|
DRP-11715
|
Paclitaxel
|
Taxitas-260
|
6 mg/mL (260 mg/43.4 mL)
|
Concentrate for Solution for Infusion
|
Antineoplastic (Taxane)
|
ADMAC Lifesciences
|
India
|
Initial
|
21 April 2022
|
21 April 2027
|