View |
|
DRP-11726
|
Ciprofloxacin (as hydrochloride)
|
None
|
500 mg
|
Film-Coated Tablet
|
-
|
Ratnamani Healthcare Pvt. Ltd.
|
India
|
Initial (Correction)
|
26 April 2023
|
22 April 2027
|
View |
|
DRP-11692
|
Gentamicin sulfate + Betamethasone (as dipropionate)
|
None
|
1 mg/500 mcg
|
Topical Cream
|
Antibiotic/Corticosteroid
|
Y.S.P. Industries (M)Sdn. Bhd
|
Malaysia
|
Initial
|
25 April 2022
|
25 April 2027
|
View |
|
DR-XY47984
|
Fenoterol hydrochloride + ipratropium bromide
|
Aerobidol
|
50 mcg/20 mcg per Actuation
|
Solution Metered Dose Inhaler
|
Selective beta-2-adrenoreceptor
Anticholinergic
|
Inpac Pharma Co., Ltd
|
Thailand
|
Initial (Correction)
|
17 October 2022
|
28 April 2027
|
View |
|
DR-XY47983
|
Budesonide
|
Aeronide
|
200mcg per actuation
|
Suspension pressurized Metered Dose Inhaler
|
Glucocorticoid
|
Inpac Pharma Co., Ltd
|
Thailand
|
Initial
|
28 April 2022
|
28 April 2027
|
View |
|
DR-XY47933
|
Omeprazole (As Sodium)
|
None
|
20 mg
|
Lyophilized Powder for Intravenous Injection/ Infusion
|
Proton Pump Inhibitor
|
Shandong Yuxin Pharmaceutical Co., Ltd.
|
China
|
-
|
25 April 2022
|
25 April 2027
|
View |
|
DR-XY47937
|
Omeprazole (As Sodium)
|
None
|
40 mg
|
Lyophilized Powder for Intravenous Injection/ Infusion
|
Proton Pump Inhibitor
|
Shandong Yuxin Pharmaceutical Co., Ltd.
|
China
|
Initial
|
25 April 2022
|
25 April 2027
|
View |
|
DRP-11720
|
Moxifloxacin (as Hydrochloride)
|
Moxiforce
|
5 mg/mL (0.5%w/v)
|
Ophthalmic Solution
|
Antiinfective (Flouroquinolone)
|
Hanlim Pharm. Co., Ltd.
|
Korea
|
Initial (Correction)
|
22 December 2023
|
22 April 2027
|
View |
|
DRP-11741
|
Furosemide
|
None
|
10mg/mL
|
Solution For Injection (IM/IV)
|
Diuretic
|
Dai Han Pharm Co., Ltd.
|
Korea
|
Initial (Correction)
|
30 January 2023
|
25 April 2027
|
View |
|
DRP-11740
|
Norepinephrine (As Bitartrate)
|
Normak
|
1 mg/mL
|
Concentrate Solution For IV Infusion
|
5 mL-capacity USP Type I Amber glass ampoule in plastic tray x 4 mL (Box of 5's)
|
Makcur Laboratories Limited
|
India
|
Initial
|
25 April 2022
|
25 April 2027
|
View |
|
DRP-11790
|
Betahistine hydrochloride
|
STEI-16
|
16mg
|
Tablet
|
Antivertigo
|
Sriprasit Pharma Co., Ltd.
|
Thailand
|
Initial
|
28 April 2022
|
28 April 2027
|
View |
|
DRP-11700
|
Omeprazole (As Sodium)
|
None
|
40 mg
|
Lyophilized Powder for Intravenous Injection/ Infusion
|
Proton pump inhibitor
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
25 April 2022
|
25 April 2027
|
View |
|
DRP-11722
|
Pioglitazone (as hydrochloride)
|
Deculin
|
15mg
|
Tablet
|
-
|
PT. Dexa Medica
|
Indonesia
|
-
|
22 April 2022
|
22 April 2027
|
View |
|
DRP-11721
|
Pioglitazone (as hydrochloride)
|
Deculin
|
30mg
|
Tablet
|
Blood Glucose Lowering Drug
|
PT. Dexa Medica
|
Indonesia
|
Initial
|
22 April 2022
|
22 April 2027
|
View |
|
DRP-10757
|
Medroxyprogesterone Acetate
|
Medwin
|
150 mg/mL
|
Suspension For Injection (I.M)
|
Hormonal Contraceptive
|
Eugia Pharma Specialities Limited
|
India
|
Initial
|
27 April 2022
|
27 April 2027
|
View |
|
DRP-10909
|
Medroxyprogesterone Acetate
|
None
|
150 mg/mL
|
Suspension For Injection (I.M)
|
Hormonal Contraceptive
|
Eugia Pharma Specialities Limited
|
India
|
Initial
|
27 April 2022
|
27 April 2027
|
View |
|
DRP-10758
|
Medroxyprogesterone Acetate
|
Medwin
|
150 mg/mL
|
Suspension for Injection (IM, Pre-Filled Syringe)
|
Hormonal Contraceptive
|
Eugia Pharma Specialities Limited
|
India
|
Initial
|
27 April 2022
|
27 April 2027
|
View |
|
DRP-10910
|
Medroxyprogesterone Acetate
|
None
|
150 mg/mL
|
Suspension For Injection (IM)
|
-
|
Eugia Pharma Specialities Limited
|
India
|
-
|
27 April 2022
|
27 April 2027
|
View |
|
DRP-11014
|
TELMISARTAN + HYDROCHLOROTHIAZIDE
|
TELMISAR PLUS
|
150 mg/mL
|
Pre-Filled Syringe
|
ANTIHYPERTENSIVE (ANGIOTENSIN II RECEPTOR BLOCKER-DIURETIC COMBINATION)
|
Eugia Pharma Specialities Limited
|
India
|
Renewal
|
02 November 2024
|
11 June 2030
|
View |
|
DRP-11015
|
Medroxyprogesterone Acetate
|
Dimple
|
150 mg/ mL
|
Suspension for Injection (IM)
|
Hormonal Contraceptive
|
Mylan Laboratories Ltd.
|
India
|
Initial
|
27 April 2022
|
27 April 2027
|
View |
|
DRP-11684
|
Citicoline (as sodium)
|
Citimak
|
250 mg/mL (1g/4 mL)
|
Solution for Injection (I.M./I.V.)
|
Psychostimulant/Nootropic
|
Makcur Laboratories Limited
|
India
|
Initial
|
13 April 2022
|
13 April 2027
|