| View |
|
DRP-9569-02
|
Paracetamol
|
Kidiron 250
|
250 mg / 5 mL
|
Suspension
|
Analgesic/Antipyretic
|
Enicar Pharmaceuticals Pvt. Ltd
|
India
|
CLIDP Conversion
|
04 January 2024
|
26 February 2026
|
| View |
|
DRP-9616-05
|
Telmisartan
|
None
|
40 mg
|
Tablet
|
Angiotensin II Receptor Blocker
|
Sapphire Lifesciences Pvt. Ltd
|
India
|
CLIDP Conversion
|
31 December 2023
|
25 March 2026
|
| View |
|
DRP-9984-03
|
Telmisartan + Hydrochlorothiazide
|
Telmart Duo
|
80 mg/12.5 mg
|
Tablet
|
Angiotensin II Receptor Blocker + Diuretic
|
Evertogen Life Sciences Limited
|
India
|
Renewal
|
13 June 2024
|
14 June 2029
|
| View |
|
DR-XY48951
|
Paracetamol + Ibuprofen (as sodium dihydrate)
|
Fasrel
|
325 mg / 200 mg
|
Tablet
|
-
|
UNILAB, Inc.
|
Philippines
|
Initial
:
|
28 December 2023
|
28 December 2028
|
| View |
|
DRP-14749
|
Ferrous Sulfate + Folic Acid
|
Aperus F
|
300 mg (equivalent to 90 mg elemental Iron)/ 250 mcg
|
Film-Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
28 December 2023
|
28 December 2028
|
| View |
|
DRP-14750
|
Ferrous Sulfate + Folic Acid
|
Rapirus
|
300 mg (equivalent to 90 mg elemental Iron)/ 250 mcg
|
Film-Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
28 December 2023
|
28 December 2028
|
| View |
|
DRP-14752
|
Paracetamol + Phenylephrine hydrochloride
|
Biosaphen
|
325 mg 10 mg
|
Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
28 December 2023
|
28 December 2028
|
| View |
|
DRP-14763
|
Acetylcysteine
|
Cilestine
|
600mg
|
Powder For Oral Solution
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
29 December 2023
|
29 December 2028
|
| View |
|
DRP-14765
|
Tranexamic Acid
|
Hemoflaz
|
100 mg/mL
|
Solution for Injection (IV)
|
Antifibrinolytic
|
Scott-Edil Pharmacia Limited
|
India
|
Initial (Correction)
|
26 February 2024
|
29 December 2028
|
| View |
|
DR-XY48968
|
Ondansetron (as hydrochloride dihydrate)
|
Strobon
|
4mg / 5 mL
|
Oral Solution
|
-
|
Limited Liability Company "Kusum Pharm"
|
Ukraine
|
Monitored Release
|
28 December 2023
|
28 December 2028
|
| View |
|
DRP-14764
|
Sevoflurane
|
Sevosaphrane
|
100% v/v
|
Volatile Liquid for Inhalation
|
-
|
Althea Pharma Pvt. Ltd.
|
India
|
Initial
|
02 January 2024
|
02 January 2029
|
| View |
|
DR-XY48969
|
Aciclovir
|
Klozivex
|
50 mg/g (5% w/w)
|
Topical Ointment
|
-
|
ENCUBE ETHICALS PVT. LTD.
|
India
|
Initial
|
02 January 2024
|
02 January 2029
|
| View |
|
DRP-14774
|
Ipratropium bromide + Salbutamol (as sulfate)
|
Ipramed
|
2.5 mg/500 mcg per 2.5 mL
|
Solution for Inhalation
|
-
|
Joincare Haibin Pharmaceutical Co., Ltd.
|
China
|
Initial
|
02 January 2024
|
02 January 2029
|
| View |
|
DRP-14751
|
Multivitamins + Iron
|
Vitgen Plus
|
Each capsule contains:
Iron (equivalent to 325 my Ferrous fumarate) 107 my
Ascorbic Acid (Vitamin C) 100 mg
Niacin (Vitamin B1) 25 mg
Thiamine mononitrate (Vitamin B1) 10 mg
Riboflavin (Vitamin B2} 10 mg
Calcium pantothenate (Vitamin B5) 10 mg
Pyridoxine hydrochloride (Vitamin B6) 5 mg
Folic Acid (Vitamin B») 950 mcg
Cyanocobalamin (Vitamin B1:) 25 mcg
|
Capsule
|
Vitamins/ Mineral
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
03 January 2024
|
03 January 2029
|
| View |
|
DRP-14754
|
Cetirizine (as hydrochloride)
|
Zetriz
|
5mg/5mL
|
Syrup (Apple Flavor)
|
-
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Initial
|
03 January 2024
|
03 January 2029
|
| View |
|
DRP-14773
|
Hydroxyethyl Starch 130/0.4
|
Acuhes 130
|
6% w/v
|
Solution for Injection for I.V. Infusion
|
-
|
Aculife Healthcare Private Limited.
|
India
|
Initial
|
02 January 2024
|
02 January 2029
|
| View |
|
DRP-14753
|
Paracetamol + Phenylephrine hydrochloride + Zinc
|
Biosaphen-Z
|
325 mg / 10 mg 10 mg (equivalent to 28 mg Zinc
Sulfate Monohydrate)
|
Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd
|
India
|
Initial
|
03 January 2024
|
03 January 2029
|
| View |
|
DRP-14775
|
Ascorbic Acid + Zinc
|
None
|
222.25 mg (equivalent to 250 mg sodium.
ascorbate)/13.73 mg (equivalent to 5 mg zinc sulfate monohydrate)
|
Chewable Tablet
|
-
|
Pharmatechnica Laboratory, Inc.
|
Philippines
|
Initial
|
03 January 2024
|
03 January 2029
|
| View |
|
DRP-14767
|
Mycophenolate Mofetil
|
Mycoglob
|
500 mg
|
Film Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
02 January 2024
|
02 January 2029
|
| View |
|
DRP-14766
|
Metoclopramide (as hydrochloride)
|
Metosky
|
5 mg/mL (10 mg/2 mL)
|
Solution for Injection (IM/IV)
|
-
|
Skymap Healthcare Pvt. Ltd.
|
India
|
Initial
|
02 January 2024
|
02 January 2029
|