| View |
|
DRP-12220
|
Montelukast (as sodium) + Levocetirizine Hydrochloride
|
Zykids
|
5 mg / 2.5 mg
|
Chewable Tablet
|
Leukotriene Receptor Antagonist/ Antihistamine
|
Ajanta Pharma Limited
|
India
|
Initial
|
21 July 2022
|
06 July 2027
|
| View |
|
DRP-12233
|
Ascorbic Acid
|
B In Cee
|
500mg (equivalent to 562.43mg Sodium Ascorbate)
|
Capsule
|
Vitamin
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
30 June 2022
|
30 June 2027
|
| View |
|
DRP-12234
|
Bromhexine Hydrochloride
|
Expell
|
8 mg
|
Tablet
|
Mucolytic
|
Phil. United Pharma Corp.
|
Philippines
|
Initial (OTC)[PCPR)
|
30 June 2022
|
30 June 2027
|
| View |
|
DRP-12295
|
Ambroxol Hydrochloride
|
Docxol
|
30 mg
|
Tablet
|
Mucolytic
|
Phil. United Pharma Corp.
|
Philippines
|
Initial (OTC][PCPR)
|
08 July 2022
|
08 July 2027
|
| View |
DR-XY48162_PI_01.pdf
|
DR-XY48162
|
Lorlatinib
|
Lorviqua
|
25 mg
|
Film-Coated Tablet
|
-
|
Pfizer Manufacturing Deutschland GmbH
|
Germany
|
Monitored Release
|
04 July 2022
|
04 July 2027
|
| View |
DR-XY48163_PI_01.pdf
|
DR-XY48163
|
Lorlatinib
|
Lorviqua
|
100 mg
|
Film-Coated Tablet
|
-
|
Pfizer Manufacturing Deutschland GmbH
|
Germany
|
Monitored Release
|
04 July 2022
|
04 July 2027
|
| View |
|
DR-XY48171
|
Paracetamol
|
Reximol
|
150 mg/mL (300 mg/2mL)
|
Solution for Injection
(I.M./I.V.)
|
Analgesic/Antipyretic
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
07 July 2022
|
07 July 2027
|
| View |
|
DRP-12287
|
Dexmedetomidine (as hydrochloride)
|
Dexmed
|
100 mcg/mL (200 mcg/2 mL)
|
Concentrate for
Solution for Intravenous Infusion
|
Hypnotic/Sedative
|
PharmIdea SIA
|
Latvia
|
Initial
|
08 July 2022
|
08 July 2027
|
| View |
DR-XY48181_PI_01.pdf
|
DR-XY48181
|
Lenalidomide
|
Linadex 10
|
10mg
|
Capsule
|
Immunosuppressant
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
12 July 2022
|
12 July 2025
|
| View |
|
DRP-12238
|
Sitagliptin (as phosphate monohydrate) + Metformin
Hydrochloride
|
Sitaform
|
50 mg/500 mg
|
Film Coated Tablet
|
Blood Glucose Lowering Drug
|
Medisure Laboratories Pakistan (Pvt.) Ltd.
|
Pakistan
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DRP-12306
|
Ceftriaxone (As Sodium)
|
Saphtriaxone
|
1g
|
Powder For Injection (IM/IV)
|
Antibacterial (third-generation cephalosporin)
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
12 July 2022
|
12 July 2027
|
| View |
|
DRP-12293
|
Tigecycline
|
Tigecid
|
50 mg
|
Lyophilized Powder for Injection for 1.V.
Infusion
|
Antibacterial (Tetracycline)
|
Centurion İlaç Sanayi Ve Ticaret A.Ş. Ankara Şubesi
|
Turkey
|
Initial
|
08 July 2022
|
08 July 2027
|
| View |
|
DRP-12311
|
Citicoline (as sodium)
|
Cholivex
|
250 mg/mL (1 g/4 mL)
|
Solution for Injection (IM/IV)
|
Psychostimulant and nootropic
|
Pharma Vision San. ve Tic. A.S.
|
Turkey
|
Initial
|
13 July 2022
|
13 July 2027
|
| View |
|
DRP-12251
|
Clindamycin Hydrochloride
|
None
|
300mg
|
Capsule
|
Antibacterial (Lincosamide)
|
AM-Europharma Corporation
|
Philippines
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DRP-12268
|
Afatinib (as dim aleate)
|
Afatin 40
|
40 mg
|
Film-Coated Tablet
|
Antineoplastic (Protein Kinase Inhibitor)
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Initial
|
06 July 2022
|
06 July 2027
|
| View |
|
DRP-12278
|
Tirofiban (as hydrochloride monohydrate)
|
Atirroxan
|
12.5 mg 150 mL (250 mcg/mL)
|
Concentrated Solution
for I.V. Infusion
|
Platelet Aggregation Inhibitor
|
Mefar Ilac Sanayii A.S.
|
Turkey
|
Initial
|
07 July 2022
|
07 July 2027
|
| View |
|
DR-XY48193
|
Apixaban
|
Thromboxain 5
|
5mg
|
Film Coated Tablet
|
Antithrombotic Agent (Direct Factor Xa Inhibitor)
|
Intas Pharmaceuticals Limited
|
India
|
Monitored Release (MR)
|
14 July 2022
|
14 July 2027
|
| View |
|
DR-XY48194
|
Apixaban
|
Thromboxain 2.5
|
2.5mg
|
Film Coated Tablet
|
Antithrombotic Agent (Direct Factor Xa Inhibitor)
|
Intas Pharmaceuticals Limited
|
India
|
Monitored Release (MR)
|
14 July 2022
|
14 July 2027
|
| View |
|
DRP-12212
|
Dexamethasone Phosphate (as Sodium)
|
Drezipex
|
4 mg/mL (8 mg/2 mL)
|
Solution for Injection (IV/IM)
|
Corticosteroid
|
Makcur Laboratories Ltd.
|
India
|
Initial
|
30 June 2022
|
30 June 2027
|
| View |
|
DR-XY48173
|
Amiodarone Hydrochloride
|
Eurythmic
|
50 mg/mL (150 mg/3 mL)
|
Concentrate Solution for Injection/Infusion (IV)
|
Anti-arrhythmic Agent
|
Troikaa Pharmaceuticals Ltd.
|
India
|
Initial (Correction)
|
10 August 2022
|
07 July 2027
|