View |
|
DRP-13272
|
Paracetamol
|
Getwel
|
500 mg
|
Tablet
|
-
|
S Kant Healthcare Ltd.
|
India
|
Initial
|
17 January 2023
|
17 January 2028
|
View |
|
DRP-13273
|
Ascorbic Acid + Cholecalciferol + Zinc
|
Immunotrio CDZ
|
Formulation:
Each capsule contains:
Ascorbic Acid..
(equivalent to 562.43 mg Sodium Ascorbate) -500 mg
Cholecalciferol..
(equivalent to 2000 1.U. Vitamin D3) 20 mg
Zinc.
(equivalent to 25 mg Zinc Gluconate) 3.6 mg
|
Capsule
|
-
|
Aldrtz Corporation
|
Philippines
|
Initial [OTC]
|
17 January 2023
|
17 January 2025
|
View |
|
DRHR-2194
|
Ethyl Alcohol
|
Alcostar
|
70% (v/v)
|
Solution with Moisturizer
|
-
|
Greatstar Laboratories
|
Philippines
|
Initial
|
17 January 2023
|
17 January 2028
|
View |
|
DRHR-2196
|
Ethyl Alcohol
|
Pro-Defense
|
70% (v/v)
|
Solution with Moisturizer
|
-
|
Medipak Manufacturing Inc.
|
Philippines
|
Initial
|
17 January 2023
|
17 January 2025
|
View |
|
DRP-13247
|
0.9% Sodium chloride
|
Polifleks
|
9 mg/mL (0.9% w/v)
|
Solution for I.V. Infusion
|
-
|
Polifarma Ilac, San Vc Tic. A.S.
|
Turkey
|
Initial (Re-application)
|
18 January 2023
|
18 January 2028
|
View |
|
DRP-13259
|
Midazolam (as Hydrochloride)
|
Dormizin
|
5 mg/mL (5 mg/ 1 mL)
|
Solution for Injection (IM/IV)
|
-
|
Ciron Drugs & Pharmaceuticals Pvt. Limited
|
India
|
Initial
|
18 January 2023
|
18 January 2028
|
View |
|
DRP-5754-09
|
CETIRIZINE DIHYDROCHLORIDE
|
CETIRGEN
|
2.5mg/mL
|
Suspension (Oral Drops) (Lemon Flavor)
|
H1 - RECEPTOR ANTAGONIST
|
J.M. Tolmann Laboratories Inc.
|
Philippines
|
Renewal
|
18 February 2024
|
12 March 2029
|
View |
|
DR-XY44890
|
Epinephrine (As Hydrochloride)
|
Eferin
|
1 mg/ mL
|
Solution for Injection (I.M./S.C./I.V.)
|
-
|
Jinling Pharamceutical Co., Ltd. Zhejiang Tianfeng Pharmaceutical Factory
|
China
|
Automatic Renewal
|
30 September 2020
|
13 November 2025
|
View |
|
BR-1437
|
Casirivimab + Imdevimab
|
Ronapreve
|
120 mg/mL
|
Concentrate for Solution for Injection
(SC)/Infusion (IV)
|
-
|
Genentech, Inc.
|
United States of America
|
Monitored Release (MR)
|
17 January 2023
|
17 January 2028
|
View |
|
DRP-10091-08
|
Norepinephrine (as bitratrate)
|
Orepine
|
1 mg/mL (4mg/mL)
|
Solution for I.V. Injection
|
-
|
Aju Pharm Co., Ltd.
|
Korea
|
-
|
21 November 2022
|
21 October 2025
|
View |
|
DR-XY48577
|
Bortezomib
|
Tezomin
|
3.5 mg
|
Lyophilized Powder For Injection (IV,SC)
|
-
|
Korea United Pharm Inc..
|
Korea
|
Initial
|
23 January 2023
|
23 January 2028
|
View |
|
DRP-13239
|
Esomeprazole (as magnesium trihydrate)
|
Esomaz
|
40 mg
|
Enteric-Coated Tablet
|
-
|
Acme Formulation Pvt. Ltd.
|
India
|
Initial
|
19 January 2023
|
19 January 2028
|
View |
|
DRP-13303
|
Docetaxel (as trihydrate)
|
Chetax-20
|
20 mg/0.5 mL
|
Concentrate Solution for Injection I.V.
Infusion
|
Antineoplastic (Taxane)
|
ADMAC Lifesciences.
|
India
|
Initial (Reconstruction)
|
31 July 2024
|
20 February 2029
|
View |
|
DRP-13308
|
Febuxostat
|
Meduroxic
|
80mg
|
Film-Coated Tablet
|
-
|
Mankind Pharma Limited (Unit II)
|
India
|
Initial
|
24 January 2023
|
24 January 2028
|
View |
|
DRP-13269
|
Telmisartan + Amlodipine (as besilate)
|
Telmisar AM- 80
|
80 mg/5 mg
|
Tablet
|
-
|
Mediwin Pharmaceuticals
|
India
|
Initial
|
20 January 2023
|
20 January 2028
|
View |
|
DRP-13301
|
Lactulose
|
Unilac
|
3.35g/5mL
|
Oral Suspension
|
-
|
KCK Pharmaceutical Industries Sdn. Bhd.
|
Malaysia
|
Initial
|
20 January 2023
|
20 January 2028
|
View |
|
BRP-120
|
Trastuzumab
|
Ogivri
|
420 mg
|
Powder for Concentrate for Solution for Infusion (IV)
|
-
|
Biocon Biologics India Limited
|
India
|
Initial
|
24 January 2023
|
24 January 2028
|
View |
|
DRP-13304
|
Etoricoxib
|
Etrobax 120
|
120 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit III)
|
India
|
Initial (Correction)
|
09 May 2023
|
20 January 2028
|
View |
|
DRP-13299
|
Mefenamic Acid
|
None
|
250 mg
|
Capsule
|
-
|
Medico Remedies Limited
|
India
|
Initial (OTC)
|
19 January 2023
|
19 January 2026
|
View |
|
DRP-13300
|
Metoclopramide (as hydrochloride)
|
Metocol
|
5 mg/mL (10 mg/2 mL)
|
Solution for Injection
(I.M./I.V.)
|
-
|
Steril-Gene Life Sciences (P) Ltd.
|
India
|
Initial
|
19 January 2023
|
19 January 2028
|