| View |
|
DRP-15108
|
Levodropropizine
|
Levotusive
|
30 mg/5 mL (6 mg/mL)
|
Syrup
|
Cough Suppressant
|
Novagen Healthcare Private Limited
|
India
|
Initial
|
02 May 2024
|
02 May 2029
|
| View |
|
DRP-15109
|
Vildagliptin
|
None
|
50 mg
|
Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
SAG Manufacturing, S.L.U.
|
Spain
|
Initial
|
02 May 2024
|
02 May 2029
|
| View |
|
DRP-15113
|
Co-Amoxiclav
|
Bioclavid
|
457 mg/5 mL
|
Powder for Oral Suspension
|
Antibacterial
|
Sandoz GmbH
|
Austria
|
Initial
|
02 May 2024
|
02 May 2029
|
| View |
|
DR-XY49065
|
Sitagliptin (as hydrochloride monohydrate)
|
Diasit 100
|
100 mg
|
Film Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Aurobindo Pharma Limited, Formulation Unit - XV
|
India
|
Initial
|
02 May 2024
|
02 May 2029
|
| View |
|
DR-XY49066
|
Sitagliptin (as hydrochloride monohydrate)
|
Diasit 50
|
50 mg
|
Film Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Aurobindo Pharma Limited, Formulation Unit - XV
|
India
|
Initial
|
02 May 2024
|
02 May 2029
|
| View |
|
DRP-15111
|
Ivabradine (as hydrochloride)
|
Ivacore
|
5 mg
|
Film Coated Tablet
|
Anti-angina
|
Baroque Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
02 May 2024
|
02 May 2029
|
| View |
|
DRP-15112
|
Ivabradine (as hydrochloride)
|
Ivacore
|
7.5 mg
|
Film-Coated Tablet
|
Anti-angina
|
Baroque Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
02 May 2024
|
02 May 2029
|
| View |
|
DRP-15110
|
Acetylcysteine
|
Lovacet
|
100 mg/mL (300 mg/3 mL)
|
Solution for Injection (IV Infusion)
|
Mucolytic
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
02 May 2024
|
02 May 2029
|
| View |
|
DR-XY49067
|
Sitagliptin (as hydrochloride monohydrate)
|
Diasit 25
|
25 mg
|
Film Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Aurobindo Pharma Limited, Formulation Unit - XV
|
India
|
Initial
|
02 May 2024
|
02 May 2029
|
| View |
|
DR-XY49069
|
Cinacalcet (as hydrochloride)
|
Cinacred 60
|
60 mg
|
Film-Coated Tablet
|
Anti-parathyroid Agent
|
Dr. Reddy's Laboratories Ltd. (FTO-Unit 2)
|
India
|
Monitored Release (MR)
|
03 May 2024
|
03 May 2029
|
| View |
|
DR-XY49070
|
Cinacalcet (as hydrochloride)
|
Cinacred 90
|
90 mg
|
Film-Coated Tablet
|
Anti-parathyroid Agent
|
Dr. Reddy's Laboratories Ltd. (FTO-Unit 2)
|
India
|
Monitored Release (MR)
|
03 May 2024
|
03 May 2029
|
| View |
|
DRP-15116
|
Hydrocortisone (as sodium succinate)
|
Cortidose 250
|
250 mg
|
Lyophilized Powder for Injection (I.M./I.V.)
|
Corticosteroid
|
Tianjin Biochemical Pharmaceutical Co., Ltd.
|
China
|
Initial
|
03 May 2024
|
03 May 2029
|
| View |
|
DRP-15115
|
Hydrocortisone (as sodium succinate)
|
Cortidose 100
|
100 mg
|
Lyophilized Powder for Injection (I.M./I.V.)
:
|
Corticosteroid
|
Tianjin Biochemical Pharmaceutical Co., Ltd.
|
China
|
Initial
|
03 May 2024
|
03 May 2029
|
| View |
|
DRP-6975-01
|
Salmeterol (As Xinafoate) + Fluticasone Propionate
|
Forair 500 DPI
|
50 mcg/500 mcg
|
Dry Powder Inhalation in Capsule
|
Anti-Asthma (Adrenergic-Corticosteroid Combination)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Automatic Renewal (Correction)
|
18 March 2021
|
25 May 2025
|
| View |
|
DRP-7995
|
Isosorbide Mononitrate
|
Nitrofix SR
|
60 mg
|
Prolonged Release Tablet
|
Anti-Angina
|
Micro Labs., Inc.
|
India
|
Renewal
|
23 November 2020
|
15 February 2025
|
| View |
|
DRP-7086-16
|
Co-Amoxiclav
|
Augimox
|
400 mg/57 mg/5 mL
|
Powder For Oral Suspension
|
Antibacterial (Penicillin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Renewal
|
02 November 2024
|
21 January 2030
|
| View |
|
DRP-10707-02
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Phytazin
|
2 g / 250 mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Zhuhai United Laboratories (Zhongshan) Co., Ltd.
|
China
|
CLIDP Conversion
|
07 April 2024
|
16 November 2026
|
| View |
|
DRP-10707-01
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
PTZ 2.25
|
2 g / 250 mg
|
Powder For Injection (IM/IV)
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Zhuhai United Laboratories (Zhongshan) Co. Ltd
|
China
|
CLIDP Conversion
|
08 December 2023
|
16 November 2026
|
| View |
|
DRP-11962-02
|
Ampicillin (as Sodium) + Sulbactam (as sodium)
|
None
|
1 g /500 mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Reyoung Pharmaceutical
|
China
|
CLIDP Conversion
|
08 December 2023
|
04 July 2027
|
| View |
|
DRP-11962-01
|
Ampicillin (as Sodium) + Sulbactam (as Sodium)
|
Retabacx-1500
|
1 g/500 mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
CLIDP Conversion
|
06 October 2023
|
24 May 2027
|