View |
|
DR-XY48439
|
Nicotine
|
2baconil TTS20
|
14 mg/24 hrs. (35 mg/20 cm2)
|
Transdermal Patch
|
Drug Used in Nicotine Dependence
|
Rusan Pharma Limited
|
India
|
Monitored Release
|
28 October 2022
|
28 October 2027
|
View |
|
DR-XY48438
|
Nicotine
|
2baconil TTS30
|
21 mg/24 hrs. (52.5 mg/30 cm2)
|
Transdermal Patch
|
Drug Used in Nicotine Dependence
|
Rusan Pharma Limited
|
India
|
Monitored Release
|
28 October 2022
|
28 October 2027
|
View |
|
DRP-12920
|
Montelukast + Levocetirizine
|
Lucazine
|
10 mg/5 mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist-Antihistamine Combination
|
Ratnamani Healthcare Pvt. Ltd.
|
India
|
Initial [Re-application
|
28 October 2022
|
28 October 2027
|
View |
|
DRP-12940
|
Olanzapine
|
None
|
10 mg
|
Film-Coated Tablet
|
Antipsychotic
|
Cadila Healthcare Limited
|
India
|
Initial (Re-application)
|
04 November 2022
|
04 November 2027
|
View |
|
DRP-12938
|
Olmesartan Medoxomil
|
Olmenov-20
|
20mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Evertogen Life Sciences Limited
|
India
|
Initial (Reapplication)
|
04 November 2022
|
04 November 2027
|
View |
|
DR-XY48435
|
Abiraterone acetate
|
Abirasun
|
250 mg
|
Tablet
|
Antineoplastic/Immunomodulating Agent (Hormone
Antagonist/Related Agent)
|
Sun Pharmaceutical Industries Limited
|
India
|
Monitored Release (Re-application) (Reconstruction)
|
24 May 2024
|
08 July 2027
|
View |
|
DR-XY48437
|
Voriconazole
|
Vorix
|
200mg
|
Lyophilized Powder for Injection (IV Infusion)
|
Antimycotics for systemic use (Triazole and tetrazole derivative)
|
Centurion İlaç Sanayi ve Ticaret A.Ş.Ankara Şubesi
|
Turkey
|
Initial
|
27 October 2022
|
27 October 2027
|
View |
|
DRP-12925
|
Bupivacaine hydrochloride (as monohydrate)
|
Duvacaine
|
5 mg/mL (0.5% w/v)
|
Solution for Injection (for Peripheral Nerve Block, Caudal Block, and Lumbar Epidural Block)
|
Local Anesthetic (Amide)
|
Pharmaniaga Lifescience Sdn. Bhd.
|
Malaysia
|
Initial
|
02 November 2022
|
02 November 2027
|
View |
|
DRP-12910
|
Benzylpenicillin (as sodium)
|
Inzocillin-1
|
1,000,000 Units
|
Powder For Injection (I.M./I.V.)
|
Antibacterial (Penicillin)
|
Injectcare Parenterals Pvt. Ltd.
|
India
|
Initial
|
27 October 2022
|
27 October 2027
|
View |
|
DRP-12900
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Zeutreme
|
4 g/500 mg
|
Powder for Injection for I.V. Infusion
|
Antibacterial (Penicillins)
|
Reyoung Pharmaceutical Co. Ltd.
|
China
|
Initial
|
27 October 2022
|
27 October 2027
|
View |
|
DRP-12911
|
Ondansetron (as hydrochloride)
|
Beludan-2
|
2 mg/mL
|
Solution For Injection (IM/IV)
|
Antiemetic (Serotonin (5-HT3) Antagonist)
|
Hiral Labs Limited
|
India
|
Initial
|
27 October 2022
|
25 October 2027
|
View |
|
DRP-12903
|
Desloratadine
|
Sylergy Neo
|
2.5 mg / 5mL
|
Syrup
|
Antihistamine
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial
|
27 October 2022
|
27 October 2027
|
View |
|
DRP-12904
|
Desloratadine
|
Alesyd
|
2.5 mg / 5mL
|
Syrup
|
Antihistamine
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial
|
27 October 2022
|
27 October 2027
|
View |
|
DRP-12883
|
Xylometazoline Hydrochloride + Lysozyme
Hydrochloride
|
Rinobact P Spray
|
0.5 mg / 0.5 mg per mL
|
Nasal Spray Solution
|
-
|
Bosnalijek D.D.
|
Bosnia and Herzegovina
|
Initial (OTC)
|
25 October 2022
|
25 October 2027
|
View |
|
DRP-12919
|
Sitagliptin (As Phosphate Monohydrate)
|
Si2norm
|
100 mg
|
Film Coated Tablet
|
Antidiabetic Agent [Dipeptidyl peptidase 4 (DPP-4) inhibitor]
|
National Healthcare Pvt. Ltd.
|
Nepal
|
Initial
|
28 October 2022
|
28 October 2027
|
View |
|
DRP-12924
|
Atracurium (as besilate)
|
Atrasyl
|
10 mg/mL (25 mg/2.5 mL)
|
Solution for IV
Injection/Infusion
|
Muscle relaxant, peripherally acting agent
|
Mefar Ilac Sanayii A.S.
|
Turkey
|
Initial
|
03 November 2022
|
03 November 2027
|
View |
|
DRP-12915
|
Atracurium (as besilate)
|
Becurium
|
10 mg/mL (25 mg/2.5 mL)
|
Solution for IV Injection/Infusion
|
Muscle relaxant, peripherally acting agent
|
Mefar llac Sanayii A.S.
|
Turkey
|
Initial
|
03 November 2022
|
03 November 2027
|
View |
|
DR-XY48456
|
Isotretinoin
|
Isonoin 10
|
10mg
|
Softgel Capsule
|
-
|
Gelnova Laboratories (India) Pvt. Ltd.
|
Thailand
|
Initial
|
04 November 2022
|
04 November 2027
|
View |
|
DR-XY48455
|
Isotretinoin
|
Isonoin 20
|
20mg
|
Softgel Capsule
|
Anti-Acne
|
Gelnova Laboratories (India) Pvt. Ltd.
|
India
|
Initial
|
04 November 2022
|
04 November 2027
|
View |
|
DRP-12901
|
Amlodipine (as Besilate)
|
Dipiglo 10
|
10mg
|
Tablet
|
Calcium Channel Blocker (Dihydropyridine Derivative)
|
Globela Pharma Private Limited
|
India
|
Initial
|
27 October 2022
|
27 October 2027
|