| View |
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DR-XY48016
|
Salmeterol Xinafoate + Fluticasone Propionate
|
Respiro
|
25mcg/250mcg
|
Metered Dose Inhaler
|
Adrenergic/ Corticosteroid
|
Deva Holding A.Ş.
|
Turkey
|
Initial
|
19 May 2022
|
19 May 2027
|
| View |
|
DRP-11833
|
Levofloxacin(As Hemihydrate)
|
Novalev
|
5mg/mL (500mg/100mL)
|
Solution For Infusion (IV)
|
-
|
Unique Pharmaceutical Laboratories (A Division of J.B Chemicals & Pharmaceuticals Ltd.)
|
India
|
Initial
|
19 May 2022
|
19 May 2027
|
| View |
|
DRP-11905
|
Olanzapine
|
Olandus 10
|
10mg
|
Film-Coated Tablet
|
Antipsychotic
|
Cadila Healthcare Limited
|
India
|
Initial
|
19 May 2022
|
19 May 2027
|
| View |
|
DRP-11876
|
Cefazolin (as Sodium)
|
Baczin
|
1g
|
Powder For Injection (IM/IV)
|
-
|
NCPC Hebei Huamin Pharmaceutical Company
Limited
|
China
|
Initial
|
18 May 2022
|
18 May 2027
|
| View |
|
DRP-11898
|
Ceftriaxone (As Sodium)
|
Triamax-1000
|
1g
|
Powder For Injection (IM/IV)
|
Antibacterial (Third-generation cephalosporin)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
18 May 2022
|
18 May 2027
|
| View |
|
DR-X576
|
Paracetamol
|
Aeknil
|
150mg/mL
|
Solution for Injection (I.M./I.V.)
|
-
|
Therapeutic Pharmaceuticals
|
India
|
Automatic Renewal
|
19 May 2022
|
12 May 2025
|
| View |
|
DR-XY37252
|
d-Alpha Tocopherol (Vitamin E)
|
Elaia
|
400 I.U.
|
Capsule
|
Vitamin
|
Capsugel (Thailand) Co., Ltd.
|
Thailand
|
Renewal
|
11 May 2022
|
23 December 2024
|
| View |
|
DR-XY48033
|
Sevoflurane
|
Sevoflex
|
100% v/v
|
Liquid for Inhalation
|
General Anesthetic
|
Shanghai Hengrui Pharmaceutical Co., Ltd.
|
China
|
Initial
|
20 May 2022
|
20 May 2027
|
| View |
|
DRP-10649
|
Mecobalamin
|
Mefredzil-1500
|
500 mcg/mL
|
Solution for Injection (IM/IV)
|
Vitamin
|
Cooper Pharma Limited
|
India
|
Initial
|
20 May 2022
|
20 May 2027
|
| View |
DR-XY48024_PI_01.pdf
|
DR-XY48024
|
Hyoscine N-Butylbromide
|
Copan
|
20mg/mL
|
Solution for Injection (I.M./I.V.)
|
Anticholinergic
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
18 May 2022
|
18 May 2027
|
| View |
|
DRP-11882
|
Salbutamol (as sulfate) + Ipratropium (as bromide)
|
Salbunov Plus
|
2.5 mg/500 mcg per 2.5 mL
|
Solution for Inhalation
|
Adrenergics in combination with anticholinergic
|
Ahlcon Parenterals (India) Limited
|
India
|
Initial
|
16 May 2022
|
16 May 2027
|
| View |
|
DRP-11903
|
Cetirizine Dihydrochloride
|
Allerjec
|
2.5mg/5mL
|
Syrup (Drops) (Grape flavor)
|
Anthisitamine
|
Mascot Health Series Pvt. Ltd.
|
India
|
Initial
|
18 May 2022
|
18 May 2027
|
| View |
|
DR-8750-01
|
Pregabalin
|
Pregabur
|
75mg
|
Capsule
|
Antiepileptic
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial (Compliance)
|
04 May 2022
|
21 February 2025
|
| View |
|
DR-XY 47860
|
Calcium Folinate
|
Folivell
|
10mg/mL (50mg/5mL)
|
Solution For Injection (IM/IV)
|
Detoxifying Agents for Antineoplastic Treatment
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial (Correction)
|
18 May 2022
|
30 March 2027
|
| View |
|
DR-XY43222
|
Rosuvastatin (as Calcium)
|
Lustatin 10
|
10 mg
|
Tablet
|
Antilipidemic
|
SIMPEX PHARMA PVT. LTD.
|
India
|
Renewal
|
07 February 2024
|
19 February 2029
|
| View |
|
DR-XY43223
|
Rosuvastatin (As Calcium)
|
Lustatin-20
|
20 mg
|
Tablet
|
Antilipidemic
|
SIMPEX PHARMA PVT. LTD.
|
India
|
Initial
|
06 February 2024
|
26 February 2029
|
| View |
|
DRHR-2141
|
Sebo de Macho
|
Unbranded
|
Formulation: Each 100 g contains: Stearic Acid-24 grams (24% v/v) Oleic Acid -12 grams (12% v/v)
|
Topical Ointment
|
Moisturizer
|
J. Chemie Laboratories, Inc.
|
Philippines
|
Renewal
|
04 May 2024
|
24 May 2029
|
| View |
|
DRP-11966
|
Ambroxol
|
Ambrorex
|
30 mg
|
Tablet
|
Mucolytic
|
Next Wave (India)
|
India
|
Initial (OTC)
|
24 May 2022
|
24 May 2027
|
| View |
|
BR-1404
|
Rituximab
|
Ruxience
|
10mg/mL
|
Concentrate for Solution for Infusion (IV)
|
Monoclonal Antibodies
|
Pfizer Manufacturing Belgium NV
|
Belgium
|
Initial
|
30 May 2022
|
30 May 2027
|
| View |
|
DRP-12015
|
Metformin hydrochloride
|
Gluventa PR 750
|
750 mg
|
Extended-Release Tablet
|
Blood Glucose Lowering Drug (Biguanide)
|
Inventia Healthcare Limited
|
India
|
Initial
|
30 May 2022
|
30 May 2027
|