| View |
|
DRP-11946
|
Ofloxacin
|
Floaxa
|
3mg/mL (0.3%w/v)
|
Ophthalmic Solution
|
Anti-infective (Flouroquinolone)
|
Axa Parenterals Limited
|
India
|
Initial (Reconstruction)
|
12 August 2024
|
23 May 2027
|
| View |
|
DR-XY48066
|
Emedastine (as Difumarate)
|
Allesaga Patch
|
8 mg
|
Transdermal Patch
|
Antihistamine
|
Hisamitsu Pharmaceutical Co., Inc. (Tosu Plant)
|
Japan
|
Monitored Release
|
30 May 2022
|
30 May 2025
|
| View |
|
DRP-11958
|
Alendronic acid (as alendronate sodium trihydrate)
|
Aldrovid
|
70mg
|
Tablet
|
Bisphosphonate
|
Hovid Berhad
|
Malaysia
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DRP-11501
|
Montelukast (as sodium)
|
Airokast
|
10 mg
|
Film-Coated Tablet
|
Leulotriene receptor antagonist
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
23 May 2022
|
23 May 2027
|
| View |
|
DR-XY48045
|
Etoricoxib
|
Arthrimed 90
|
90 mg
|
Film-Coated Tablet
|
Non-Steroidal Anti-Inflammatory Drug/Antirheumatic
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DR-XY48046
|
Etoricoxib
|
Arthrimed 120
|
120 mg
|
Film-Coated Tablet
|
Non-Steroidal Anti-Inflammatory Drug/Antirheumatic
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
26 May 2022
|
26 May 2027
|
| View |
|
DR-XY48044
|
Etoricoxib
|
Arthrimed 60
|
60 mg
|
Film-Coated Tablet
|
Non-Steroidal Anti-Inflammatory Drug/Antirheumatic
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
26 May 2022
|
26 May 2027
|
| View |
|
DRP-11830
|
Levofloxacin (As Hemihydrate)
|
Evoxa-500
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Fluoroquinolone)
|
Hiral Labs. Ltd.
|
india
|
Initial
|
20 May 2022
|
20 May 2027
|
| View |
|
DR-XY 48037
|
Ambroxol Hydrochloride
|
None
|
30 mg
|
Tablet
|
Expectorant (Mucolytic)
|
Shandong Yuxin Pharmaceutical Co., Ltd.
|
China
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DR-XY44321
|
Carboprost (As Trometamol)
|
Evacarb
|
125mcg/0.5mL and 250 mcg/mL
|
Solution For Injection (for I.M Use Only)
|
Uterotonic (Prostaglandin)
|
Celon laboratories Private Limited
|
India
|
Initial (from Monitored Release)
|
24 May 2022
|
13 March 2025
|
| View |
|
DR-XY48058
|
Finasteride
|
Prostride
|
5 mg
|
Film Coated Tablet
|
Testosterone-5-Alpha Reductase Inhibitors
|
Alkem Laboratories Limited
|
India
|
Initial
|
27 May 2022
|
27 May 2027
|
| View |
|
DR-XY48032
|
Fingolimod (As Hydrochloride)
|
Relsis
|
500 mcg
|
Capsule
|
Immunosuppressant
|
Alkem Laboratories Limited
|
India
|
MR-INT
|
24 May 2022
|
24 May 2027
|
| View |
|
DRP-11934
|
Piperacillin &Tazobactam
|
Pipertaz
|
4g/500mg
|
Powder for Intravenous (IV) Infusion
|
Antibacterial (Penicillin/ Beta-lactamase Inhibitor)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
20 May 2022
|
20 May 2027
|
| View |
|
DRP-11981
|
Tranexamic Acid
|
Ranex
|
100 mg/mL
|
Solution for Injection (IV)
|
-
|
Steril-Gene Life Sciences (P) Ltd.
|
India
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DRP-11984
|
Bupivacaine hydrochloride in Dextrose
|
S-Bupi Heavy
|
5 mg/80mg per mL
|
Solution for Injection (Intrathecal)
|
Local Anaesthetic
|
Steril-Gene Life Sciences (P) Ltd.
|
India
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DRP-11980
|
Furosemide
|
Furonova
|
10 mg/ml
|
Solution for Injection (IM/IV)
|
Diuretic
|
Steril-Gene Life Sciences (P) Ltd.
|
India
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DRP-11993
|
Travoprost
|
Travqure
|
40 mcg/mL (0.004% w/v)
|
Sterile Ophthalmic Solution
(Drops)
|
Antiglaucoma Preparation and Miotic (Prostaglandin 8 Analogue)
|
Indoco Remedies Limited
|
India
|
Initial
|
26 May 2022
|
26 May 2025
|
| View |
|
DRP-11992
|
Moxifloxacin (as hydrochloride)
|
Vigaqure
|
5 mg/mL (0.5% w/v)
|
Ophthalmic Solution (Drops)
|
Antiinfective (Flouroquinolone)
|
Indoco Remedies Limited
|
India
|
Initial
|
26 May 2022
|
26 May 2025
|
| View |
|
DRP-11919
|
Imidapril Hydrochloride + Hydrochlorothiazide
|
Vascoride
|
10 mg/12.5 mg
|
Tablet
|
Angiotensin Converting Enzyme (ACE) Inhibitor / Diuretic
|
Amherst laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
08 July 2022
|
12 September 2027
|
| View |
|
DRP-12003
|
Piperacillin (As Sodium) + Tazobactam (As Sodium)
|
None
|
4 g/500 mg
|
Powder For Injection (I.V)
|
-
|
Aurobindo Pharma Limited (Unit XII)
|
India
|
Initial
|
27 May 2022
|
27 May 2027
|