| View |
|
DRP-12620
|
Captopril
|
Capnock
|
25 mg
|
Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
15 September 2022
|
15 September 2027
|
| View |
|
DRP-12619
|
Captopril
|
None
|
25 mg
|
Tablet
|
Angiotensin-Converting Enzyme (ACE) inhibitor
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
15 September 2022
|
15 September 2027
|
| View |
|
DR-XY48334
|
Cefoperazone + Sulbactam
|
Xefrizil
|
500 mg/500 mg
|
Powder for Injection (I.V./I.M.)
|
Antibacterial (Cephalosporin/Beta-Lactamase
Inhibitor)
|
Vellinton Healthcare
|
India
|
Initial
|
14 September 2022
|
14 September 2027
|
| View |
|
DRP-12581
|
Cefuroxime (As Axetil)
|
Hiroxime-125
|
125 mg/5 mL
|
Powder For Oral Suspension
|
Antibacterial (Cephalosporin)
|
Hiral Labs Limited
|
India
|
Initial (correction)
|
03 November 2022
|
07 September 2027
|
| View |
|
DR-XY48347
|
Leflunomide
|
Bageda
|
20mg
|
Film-Coated Tablet
|
-
|
World Medicine İlaç Sanayi Ve Ticaret A.Ş.
|
Turkey
|
Monitored Release
|
12 September 2022
|
12 September 2027
|
| View |
|
DRP-12631
|
Thiamine Mononitrate (Vitamin B1) + Pyridoxine Hydrochloride (Vitamin B6) + Cyanocobalamin
(Vitamin B12)
|
None
|
500 mg/ 250 mg/ 1 mg
|
Film Coated Tablet
|
Vitamins
|
Phil. United Pharma Corp.
|
Philippines
|
Initial
|
16 September 2022
|
16 September 2027
|
| View |
|
HRP-542
|
Povidone-Iodine
|
Povi-Guard
|
100 mg/mL (10% w/v) (equivalent to 1% w/v Iodine)
|
Swab Pad
|
-
|
Nagindas Hiralal Bhayani
|
India
|
Initial (HR)
|
12 September 2022
|
12 September 2027
|
| View |
|
DRP-12569
|
Rifampicin + Isoniazid + Pyrazinamide
|
HRZ Pedia DT
|
75 mg/50 mg/150 mg
|
Dispersible Tablet
|
Antituberculosis
|
Oxalis Labs
|
India
|
Initial
|
06 September 2022
|
06 September 2027
|
| View |
DR-XY48349_PI_01.pdf
|
DR-XY48349
|
Emtricitabine + Dolutegravir (as sodium) + Tenofovir The alafenamide (as hemifumarate)
|
None
|
200 mg/50 mg/25 mg
|
Film-Coated Tablet
|
Antiretroviral (Direct Acting Antivirals)
|
Hetero Labs Limited (Unit III)
|
India
|
Monitored Release (MR
|
13 September 2022
|
13 September 2027
|
| View |
BR-1418_PI_01.pdf
|
BR-1418
|
Ofatumumab
|
Bonspri
|
20 mg/ 0.4 mL
|
Solution for Injection (SC)
|
Immunosuppressants
|
Novartis Pharma Stein AG (Technical Operations Schweiz, Stein Steriles)
|
Switzerland
|
Monitored Release (MR)
|
12 September 2022
|
12 September 2027
|
| View |
|
DRP-12582
|
Aciclovir (As Sodium)
|
Bizaclovir
|
250 mg
|
Lyophilized Powder For Injection (IV Infusion)
|
-
|
Laboratorio Reig Jofre S.A.
|
Spain
|
Automatic Renewal (Variation)
|
14 September 2022
|
14 September 2027
|
| View |
DRP-1589_PIL_01.pdf
|
DRP-1589
|
Thiamine Mononitrate (Vitamin B1) + Pyridoxine Hydrochloride (Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
Marvit
|
100 mg/ 5 mg/ 50 mcg
|
Capsule
|
VITAMINS
|
St. Martin Pharmaceutical Laboratory
|
Philippines
|
Automatic Renewal
|
09 June 2023
|
15 July 2028
|
| View |
|
DRP-12584
|
Ceftriaxone (as sodium)
|
Ceftrihil
|
1g
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Third-Generation Cephalosporin)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
08 September 2022
|
08 September 2027
|
| View |
|
DR-XY48344
|
Roxadustat
|
Evrenzo
|
20 mg
|
Film-Coated Tablet
|
-
|
Catalent Pharma Solutions LLC
|
United States of America
|
Monitored Release
|
08 September 2022
|
08 September 2027
|
| View |
|
DR-XY48343
|
Roxadustat
|
Evrenzo
|
50 mg
|
Film-Coated Tablet
|
-
|
Catalent Pharma Solutions LLC
|
United States of America
|
Monitored Release
|
08 September 2022
|
08 September 2027
|
| View |
|
DR-XY48339
|
Thiocolchicoside
|
Thiozz-8
|
8 mg
|
Orodispersible Tablet
|
Muscle Relaxant
|
Ipca Laboratories Ltd.
|
India
|
Monitored Release
|
06 September 2022
|
06 September 2027
|
| View |
|
DR-XY48354
|
Bisoprolol Fumarate
|
Bisodac 2.5
|
2.5mg
|
Film-Coated Tablet
|
Beta Blocking Agent
|
Aurobindo Pharma Limited
|
india
|
Initial
|
15 September 2022
|
15 September 2027
|
| View |
|
DR-XY48352
|
Bisoprolol Fumarate
|
Bisodac 5
|
5mg
|
Film-Coated Tablet
|
Beta Blocking Agent
|
Aurobindo Pharma Limited
|
India
|
Initial
|
15 September 2022
|
15 September 2027
|
| View |
|
DR-XY29254
|
Simvastatin
|
None
|
40 mg
|
Film-Coated Tablet
|
-
|
Amherst laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
09 September 2022
|
06 June 2027
|
| View |
|
DRP-12574
|
Meropenem (as trihydrate)
|
B-PENEM IV
|
500 mg
|
Powder for Injection (IV)
|
Antibacterial (Carbapenem)
|
Brooks Laboratories Limited
|
India
|
Initial
|
14 September 2022
|
14 September 2027
|