| View |
|
DRP-11018
|
Cefepime (As Hydrochloride)
|
Novafime
|
1g
|
Powder For Injection (IM/IV)
|
Antibacterial (Cephalosporin)
|
Swiss Parenterals Ltd.
|
India
|
Initial
|
18 January 2022
|
18 January 2027
|
| View |
|
DR-XY47614
|
Cefuroxime (As Axetil)
|
None
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
J.M. Tolmann Laboratories, Inc.
|
Philippines
|
Initial
|
18 January 2022
|
18 January 2027
|
| View |
DR-XY47689_PI_01.pdf
|
DR-XY47689
|
Levetiracetam
|
Leveget
|
750mg
|
Film-Coated Tablet
|
Antiepileptic
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
26 January 2022
|
26 January 2027
|
| View |
|
DRP-11095
|
Sevoflurane
|
Sevofran
|
100% v/v
|
Volatile Liquid For Inhalation
|
General Anesthetic
|
Hana Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
28 January 2022
|
28 January 2027
|
| View |
|
DRP-11020
|
Prednisolone (As sodium Phosphate)
|
Drenisole
|
20mg/5mL
|
Syrup (Vanilla-Strawberry Flavor)
|
Corticosteroid
|
LifeSquare Laboratories, Inc.
|
Philippines
|
Initial
|
18 January 2022
|
18 January 2027
|
| View |
|
DRP-11019
|
Silver Sulfadiazine
|
Revsil
|
10 mg/g (1% w/w)
|
Cream
|
Antibacterial (Sulfonamide)
|
LifeSquare Laboratories, Inc.
|
Philippines
|
Initial
|
18 January 2022
|
18 January 2027
|
| View |
|
DRP-11078
|
Racecadotril
|
None
|
30 mg
|
Granules for Oral Suspension
|
Antidiarrheal
|
Athena Drug Delivery Solutions Pvt. Ltd.
|
India
|
Initial
|
26 January 2022
|
26 January 2027
|
| View |
|
DRP-11085
|
Racecadotril
|
None
|
10 mg
|
Granules For Oral Suspension
|
Antidiarrheal
|
Athena Drug Delivery Solutions Pvt. Ltd.
|
India
|
Initial
|
26 January 2022
|
26 January 2027
|
| View |
|
DRP-11047
|
Telmisartan
|
None
|
80 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
19 January 2022
|
19 January 2027
|
| View |
|
DR-XY47690
|
Lemborexant
|
Dayvigo
|
5mg
|
Film-Coated Tablet
|
Orexin Receptor Antagonist
|
Eisai Manufacturing Limited
|
United Kingdom
|
Monitored Release
|
28 January 2022
|
28 January 2027
|
| View |
|
DR-XY47691
|
Lemborexant
|
Dayvigo
|
10mg
|
Film-Coated Tablet
|
Orexin Receptor Antagonist
|
Eisai Manufacturing Limited
|
United Kingdom
|
Monitored Release
|
28 January 2022
|
28 January 2027
|
| View |
|
DRP-10930
|
Fenofibrate
|
Fenosaph-200
|
200 mg
|
Micronized Capsule
|
Lipid Modifying Agent (Fibrate)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
18 January 2022
|
18 January 2027
|
| View |
DR-XY44705_PI_01.pdf
|
DR-XY44705
|
Indapamide + Amlodipine (as besilate)
|
Natrixam
|
1.5mg/10mg
|
Modified-Release Tablet
|
-
|
Les Laboratoires Servier Industrie
|
France
|
Initial (From Monitored Release)
|
30 May 2022
|
07 July 2025
|
| View |
DR-XY44704_PI_01.pdf
|
DR-XY44704
|
Indapamide + Amlodipine (as besilate)
|
Natrixam
|
1.5 mg/5 mg
|
Modified-Release Tablet
|
Antihypertensive (Diuretic/Calcium Channel Blocker)
|
Les Laboratoires Servier Industrie
|
France
|
Initial (from Monitored Release)
|
30 May 2022
|
07 July 2025
|
| View |
|
DR-XY44203
|
Fluticasone Furoate + Vilanterol (as trifenatate)
|
Relvar Ellipta
|
200 mcg/25 mcg (equivalent to 184 mcg/22 mcg
delivered dose)
|
Dry Powder For Inhalation
|
-
|
Glaxo Operations UK Ltd.
|
United Kingdom
|
Initial [from Monitored Release] Reconstruction
|
06 June 2022
|
13 February 2025
|
| View |
|
DR-XY44202
|
Fluticasone Furoate + Vilanterol (As Trifenatate)
|
Relvar Ellipta
|
100mcg/25mcg (eq. to 92mcg/22 mcg delivered dose
|
Dry Powder For Inhalation
|
-
|
Glaxo Operations UK Ltd.
|
United Kingdom
|
Initial [from Monitored Release]
|
17 March 2022
|
13 February 2025
|
| View |
|
DRP-5119-01
|
Salmeterol (As Xinafoate) + Fluticasone Propionate
|
Evoflo
|
25 mcg/125 mcg
|
Metered Dose Inhaler (Suspension)
|
Beta-2-Adrenoceptor Agonist/ Corticosteroid
|
Glaxo Wellcome S.A.
|
Spain
|
Initial (Variation)
|
04 November 2022
|
25 July 2027
|
| View |
|
DR-XY46384
|
Gemcitabine (As Hydrochloride)
|
Zytogem
|
200mg
|
Lyophilized Powder For IV Infusion
|
-
|
Ildong Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
24 May 2022
|
25 June 2025
|
| View |
|
DR-XY46385
|
Gemcitabine (As Hydrochloride)
|
Zytogem
|
1g
|
Lyophilized Powder for IV Infusion
|
-
|
Ildong Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
21 May 2021
|
25 June 2025
|
| View |
|
DR-XY44283
|
SALBUTAMOL (AS SULFATE) + BECLOMETASONE DIPROPIONATE
|
IBICAR S
|
100 mcg/50 mcg per metered dose
|
Pressurized Suspension
for Inhalation
|
BRONCHODILATOR/CORTICOSTEROID
|
Glenmark Pharmaceuticals Ltd.
|
India
|
Renewal
|
27 September 2024
|
11 March 2030
|