| View |
|
DR-XY48304
|
Cetirizine Hydrochloride
|
Simtec
|
10mg
|
Tablet
|
Antihistamine
|
Duopharma Manufacturing (Bangi) Sdn. Bhd.
|
Malaysia
|
Initial (OTC)
|
19 August 2022
|
19 August 2027
|
| View |
|
DRP-12487
|
Diclofenac Sodium
|
Diclotrue
|
25 mg/ mL
|
Solution for Injection (IM/IV)
|
Non-steroidal Anti-inflammatory and Anti-rheumatic
|
Cooper Pharma Limited
|
India
|
Initial (Correction)
|
20 January 2023
|
18 August 2027
|
| View |
|
DRP-12477
|
Azithromycin (as dihydrate)
|
Zenith OD
|
200 mg/5 mL
|
Powder for Oral Suspension
|
Antibacterial (Macrolide)
|
Zim Laboratories Limited
|
India
|
Initial
|
17 August 2022
|
17 August 2027
|
| View |
|
DR-XY48308
|
Escitalopram (As Oxalate)
|
Escit
|
10mg
|
Film Coated Tablet
|
-
|
Celogen Generics Private Ltd.
|
India
|
Initial
|
22 August 2022
|
22 August 2027
|
| View |
|
DRP-12466
|
Salmeterol Xinafoate + Fluticasone Propionate
|
Seroflo 250 Ciphaler
|
50 mcg / 250 mcg
|
Powder for Inhalation
|
-
|
Cipla Limited Indore Sez (Unit IV)
|
India
|
Initial (Rx)
|
16 August 2022
|
16 August 2027
|
| View |
|
DRP-12467
|
Salmeterol Xinafoate + Fluticasone Propionate
|
Seroflo 100 Ciphaler
|
50 mcg/100mcg
|
Powder for Inhalation
|
-
|
Cipla Limited Indore Sez (Unit IV)
|
India
|
Initial (Rx)
|
16 August 2022
|
16 August 2027
|
| View |
|
DRP-12495
|
Clonidine Hydrochloride
|
Clonisaph-75
|
75 mcg
|
tablet
|
Antihypertensive (Imidazoline Receptor Agonist)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
19 August 2022
|
19 August 2027
|
| View |
|
DRP-12494
|
Clonidine Hydrochloride
|
Clonisaph-150
|
150 mcg
|
Tablet
|
Antihypertensive (Imidazoline Receptor Agonist)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
19 August 2022
|
19 August 2027
|
| View |
|
DRP-12501
|
Cefixime (As Trihydrate)
|
Kepxime
|
400mg
|
Capsule
|
Antibacterial (Cephalosporin)
|
Sakar Healthcare Pvt. Ltd.
|
india
|
Initial
|
19 August 2022
|
19 August 2027
|
| View |
|
DRP-8422-01
|
Mupirocin + Betamethasone (As Dipropionate)
|
Mupirina-B
|
20 mg (2%)/ 500 mcg (0.05%) per gram
|
Ointment
|
-
|
Glenmark Pharmaceuticals Ltd.
|
India
|
Initial (Reconstruction)
|
23 August 2022
|
04 January 2026
|
| View |
|
DR-XY48313
|
Paclitaxel
|
None
|
6 mg/ mL (100 mg/16.7 mL)
|
Solution for Injection (IV Infusion)
|
-
|
Eskayef Pharmaceuticals Limited - Rupganj Plant
|
Bangladesh
|
Initial
|
08 August 2022
|
08 August 2027
|
| View |
|
DRP-1475-03
|
Amoxicillin (as Trihydrate)
|
None
|
500 mg
|
Capsule
|
Antibacterial (Penicillin)
|
J.M. Tolmann Laboratories, Inc.
|
Philippines
|
-
|
08 September 2022
|
10 May 2027
|
| View |
|
DRP-3915-02
|
Candesartan Cilexetil
|
Candego-8
|
8 mg
|
Tablet
|
Angiotensin II Antagonists
|
Stallion Laboratories Pvt. Ltd
|
India
|
-
|
08 September 2022
|
14 August 2027
|
| View |
|
DRP-5683-17
|
CEFIXIME
|
CEFZIN
|
20 mg/mL
|
Granules for Suspension (Oral Drops)
|
ANTIBACTERIAL (CEPHALOSPORIN)
|
J.M. Tolmann Laboratories Inc
|
Philippines
|
Renewal
|
01 March 2024
|
20 February 2029
|
| View |
|
DRP-8058-03
|
Losartan Potassium
|
Lilasartan
|
50 mg
|
Film-Coated Tablet
|
-
|
Hiral Labs Limited
|
India
|
-
|
08 September 2022
|
29 April 2026
|
| View |
|
DRP-9359-01
|
Rocuronium bromide
|
Medcurom
|
10 mg/mL (50 mg/5 mL)
|
Solution for Injection (I.V.)
|
Muscle Relaxant
|
Maiva Pharma Private Limited
|
India
|
-
|
08 September 2022
|
04 December 2025
|
| View |
|
DRP-11203-04
|
Anastrozole
|
Anastragen
|
1mg
|
Film-Coated Tablet
|
Aromatase Inhibitor
|
Jodas Expoim Pvt. Ltd.
|
India
|
-
|
08 September 2022
|
02 March 2027
|
| View |
|
DRP-11620-03
|
Febuxostat
|
Febox-40
|
40 mg
|
Film-Coated Tablet
|
Antigout
|
Gracure Pharmaceutical Ltd.
|
India
|
-
|
08 September 2022
|
04 April 2027
|
| View |
|
DRP-11661-02
|
Propofol
|
Profol-S
|
10 mg/mL
|
Emulsion For Injection (I.V)
|
General Anesthetic
|
Daewon Pharm. Co., Ltd.
|
Republic of Korea
|
Automatic Renewal
|
20 September 2022
|
07 April 2027
|
| View |
|
DRP-11837-02
|
Losartan Potassium + Amlodipine (as besilate)
|
Duo Card
|
50 mg/5 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blockers (ARBs) and Calcium Channel Blocker
|
Stallion Laboratories Pvt. Ltd.
|
India
|
-
|
07 September 2022
|
10 February 2025
|