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DR-XY47651
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Zinc Oxide + Myroxylon balsamum var. pereirae
(Royle) Harms (Balsam of Peru) Resin + Benzyl
Benzoate
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Anucare
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107.5mg/18.8mg/12.5mg per g Ointment
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Ointment
|
-
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Y.S.P. Industries (M) Sdn. Bhd.
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Malaysia
|
-
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05 January 2022
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05 January 2027
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DRP-11029
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Progesterone
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Amprofem
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200 mg
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Soft gelatin capsule
|
-
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Akums Drugs & Pharmaceuticals Ltd. (Plant IV
Hormonals)
|
India
|
-
|
06 January 2022
|
06 January 2027
|
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DR-XY47649
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Per Kit contains:
Sitagliptin (as phosphate monohydrate) 50 mg Film Coated Tablet + Metformin hydrochloride 1 g
Extended Release Tablet
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Adivia Met
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Per Kit contains:
Sitagliptin (as phosphate monohydrate) 50 mg Film Coated Tablet + Metformin hydrochloride 1 g
Extended Release Tablet
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Dipeptidyl peptidase 4 (DPP-4) inhibitor/ Oral
Hypoglycemic (Biguanide)
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-
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Lloyd Laboratories, Inc.
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Philippines
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-
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07 January 2022
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07 January 2027
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DRP-11060
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Salbutamol (as sulfate)
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Salrite
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2.5 mg/2.5 mL
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Solution for Nebulization
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Selective beta-2 adrenergic agonist
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Legency Remedies Pvt. Ltd.
|
India
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Automatic Renewal
|
07 April 2022
|
21 January 2027
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DRP-11062
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Salbutamol (as Sulfate) + Ipratropium Bromide
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Duorite Respules
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2.5 mg/500 mcg per 2.5 mL
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Solution for Nebulization
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Adrenergic/Anticholinergic
|
Legency Remedies Pvt. Ltd.
|
India
|
Initial
|
21 January 2022
|
21 January 2027
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DRP-11035
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Pregabalin
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Prebaga-75
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75 mg
|
Capsule
|
Antiepileptic
|
Zim Laboratories Limited
|
India
|
Initial
|
11 January 2022
|
11 January 2027
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DRP-11061
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Azithromycin (As Dihydrate)
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Azipro
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500mg
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Film-coated tablet
|
-
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Corona Remedies Private Limited
|
India
|
-
|
21 January 2022
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21 January 2027
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DR-XY47688
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Salbutamol (As Sulfate)
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Aerotamol
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100mcg
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Metered Dose Inhaler (200 Actuation)
|
Selective beta-2 adrenergic agonist
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Inpac Pharma Co. Ltd
|
Thailand
|
Initial (Correction)
|
19 January 2023
|
26 January 2027
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DRHR-2122
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Symclosene (Trichloroisocyanuric Acid)
|
Aqua Inline
|
200 grams
|
Tablet
|
Water Disinfectant
|
Medentech Limited
|
Ireland
|
Renewal
|
07 February 2024
|
28 January 2029
|
| View |
DRP-11076_PI_01.pdf
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DRP-11076
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Propofol
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Proanes
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10 mg/mL (1% w/v)
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Emulsion for Injection (I.V./Infusion)
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General Anesthetic (Short-acting Anesthetic)
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PT. Sanbe Farma (Unit 3)
|
Indonesia
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Initial
|
25 January 2022
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25 January 2027
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DRP-5382-01
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Ampicillin(as sodium)+Sulbactam(as sodium)
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UNAMAX
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1 g/500 mg
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Powder for Injection (IM/IV)
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Antibacterial (Combination of penicillin and beta-lactamase inhibitor)
|
Shin Poong Pharmaceutical Co., Ltd.
|
Korea
|
Renewal
|
17 April 2024
|
10 July 2029
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| View |
DRP-11052_PI_01.pdf
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DRP-11052
|
Febuxostat
|
Fevorica 40
|
40 mg
|
Film-Coated Tablet
|
-
|
Acme Formulation Pvt. Ltd.
|
India
|
-
|
19 January 2022
|
19 January 2027
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DRP-11096
|
Magnesium sulfate (as heptahydrate)
|
None
|
500 mg/ mL (10 g/20 mL)
|
Solution for Injection (I.M./I.V.)
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Anticonvulsant / Anti-arrythmic Agent / Electrolyte or I.V. Additive Solution
|
Dai Han Pharm Co., Ltd.
|
Korea
|
Initial
|
28 January 2022
|
28 January 2027
|
| View |
DRP-11053_PI_01.pdf
|
DRP-11053
|
Febuxostat
|
Stabufost 40
|
40 mg
|
Film-Coated Tablet
|
-
|
Acme Formulation Pvt. Ltd.
|
India
|
-
|
19 January 2022
|
19 January 2027
|
| View |
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DRP-561-05
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Paracetamol
|
None
|
500 mg
|
Tablet
|
Analgesic/Antipyretic
|
Am-Europharma Corporation
|
Philippines
|
Renewal
|
27 January 2022
|
28 May 2025
|
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DR-XY47661
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Lenalidomide
|
Lenagen
|
10 mg
|
Capsule
|
Immunosuppressant
|
Lotus Pharmaceutical Co., Ltd. (Nantou Plant)
|
Taiwan
|
Monitored Release
|
11 January 2022
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11 January 2027
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DR-XY47660
|
Lenalidomide
|
Lenagen
|
15 mg
|
Capsule
|
Immunosuppressant
|
Lotus Pharmaceutical Co., Ltd. (Nantou Plant)
|
Taiwan
|
Monitored Release
|
11 January 2022
|
11 January 2027
|
| View |
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DR-XY47659
|
Lenalidomide
|
Lenagen
|
25 mg
|
Capsule
|
Immunosuppressant
|
Lotus Pharmaceutical Co., Ltd. (Nantou Plant)
|
Taiwan
|
Monitored Release
|
11 January 2022
|
11 January 2027
|
| View |
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DR-XY47662
|
Lenalidomide
|
Lenagen
|
5 mg
|
Capsule
|
Immunosuppressant
|
Lotus Pharmaceutical Co., Ltd. (Nantou Plant)
|
Taiwan
|
Monitored Release
|
11 January 2022
|
11 January 2027
|
| View |
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DRP-10931
|
Febuxostat
|
Urinorm
|
20 mg
|
Film-Coated Tablet
|
Anti-gout
|
Ajanta Pharma Limited
|
India
|
Initial
|
18 January 2022
|
18 January 2027
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