| View |
|
DRP-11575
|
Cefuroxime (as sodium)
|
Cefroxsur-750
|
750 mg
|
Powder for Injection (IM/IV)
|
Second Generation Cephalosporin
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
|
DRP-11576
|
Cefuroxime (as sodium)
|
Cefroxsur
|
1.5 g
|
Powder for Injection (IM/IV)
|
Second Generation Cephalosporin
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
|
DRP-11640
|
Cisplatin
|
Blatin 50
|
1 mg/mL
|
Concentrate Solution for IV Infusion
|
Antineoplastic Agent
|
Venus Remedies
|
India
|
Initial
|
05 April 2022
|
05 April 2027
|
| View |
|
DRP-11641
|
Cisplatin
|
Blatin 10
|
1 mg/mL
|
Concentrate Solution for IV Infusion
|
Antineoplastic Agent
|
Venus Remedies
|
India
|
Initial
|
05 April 2022
|
05 April 2027
|
| View |
DR-XY47879_PI_01.pdf
|
DR-XY47879
|
Bendamustine hydrochloride (as monohydrate)
|
Bentero 100
|
100 mg
|
Lyophilized Powder for Injection for I.V.
Infusion
|
-
|
Hetero Labs Limited (Unit-VI, TSIIC, Formulation
SEZ)
|
India
|
-
|
31 March 2022
|
31 March 2025
|
| View |
|
DR-XY47878
|
Montelukast Sodium + Cetirizine Hydrochloride
|
Alduet
|
10mg/10mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
-
|
01 April 2022
|
01 April 2027
|
| View |
|
DRP-10947
|
Salbutamol
|
Airway 2
|
2 mg
|
Tablet
|
Bronchodilator
|
Phil. United Pharma Corporation (PUPC)
|
Philippines
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
|
DRP-11518
|
Sodium Hyaluronate
|
Acceluron
|
1 mg/mL (0.1% w/v)
|
Ophthalmic Solution (Eye Drops)
|
-
|
Hanlim Pharm. Co., Ltd.
|
Korea
|
-
|
01 April 2022
|
01 April 2027
|
| View |
|
DRP-11649
|
Tigecycline
|
Tigecare
|
50mg
|
Lyophilized Powder for Injection (I.V. Infusion)
|
Antibacterial (Tetracycline)
|
Gland Pharma Limited
|
India
|
Initial
|
06 April 2022
|
06 April 2027
|
| View |
|
DRP-11667
|
Tramadol Hydrochloride
|
Vesnon-V100
|
50 mg/mL
|
Solution for Injection (I.M./I.V.)
|
Opioid Analgesic
|
Vesco Pharmaceutical Company Limited
|
Thailand
|
Initial
|
08 April 2022
|
08 April 2027
|
| View |
|
DR-XY47885
|
Cholecalciferol (Vitamin D3)
|
None
|
50mcg (2,000 IU)
|
Tablet (Strawberry Flavor)
|
-
|
Natrol LLC
|
United States of America
|
Initial (OTC)
|
31 March 2022
|
31 March 2026
|
| View |
|
DRP-11605
|
Cefoxitin (As Sodium)
|
Cefoxit
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
-
|
06 April 2022
|
06 April 2027
|
| View |
|
DR-XY43998
|
Ranolazine
|
Cartinex
|
500 mg
|
Extended Release Tablet
|
Anti-Angina
|
Micro Labs Limited
|
India
|
Renewal
|
02 November 2024
|
16 December 2029
|
| View |
|
DRP-11599
|
Bortezomib
|
None
|
3.5 mg
|
Lyophilized Powder for Injection (S.C./I.V.)
|
Antineoplastic Agent (Proteasome Inhibitor)
|
Eugia Pharma Specialties Limited
|
India
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
|
DR-XY47863
|
Ceftazidime (as pentahydrate)
|
Fotaran
|
1 g
|
Powder for Injection (IV/IM)
|
-
|
VHB Medi Sciences Limited
|
India
|
-
|
31 March 2022
|
31 March 2027
|
| View |
|
DR-XY47862
|
Citicoline
|
Nervcedil
|
250 mg/mL (1 g/4 mL)
|
Solution for Injection (IV/IM)
|
Other Psychostimulants and Nootropics
|
Scott-Edil Pharmacia Limited
|
India
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
|
DRP-11563
|
Adapalene
|
None
|
1 mg/g (0.1% w/w)
|
Topical Gel
|
Anti-Acne
|
Rhydburg Pharmaceuticals Ltd.
|
India
|
Initial
|
01 April 2022
|
31 March 2027
|
| View |
|
BR-1396
|
Polatuzumab vedotin
|
Polivy
|
140 mg
|
Powder for Concentrate for Solution for
Infusion (IV)
|
-
|
BSP Pharmaceuticals S.p.A.
|
Italy
|
Monitored Release
|
01 April 2022
|
01 April 2027
|
| View |
|
DRP-11630
|
Paracetamol
|
Parcetol
|
10 mg/mL (1g/100 mL)
|
Solution for I.V. Infusion
|
Analgesic / Antipyretic
|
Dai Han Pharm. Co., Ltd
|
Korea
|
Initial
|
27 July 2022
|
04 April 2027
|
| View |
|
DRP-11601
|
Ceftazidime (as pentahydrate)
|
Novazidime
|
1 g
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Cephalosporin)
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial
|
31 March 2022
|
31 March 2027
|