| View |
|
DR-XY48172
|
Domperidone
|
Dosin
|
10 mg
|
Tablet
|
Propulsive
|
Taiwan Biotech Co., Ltd.
|
Taiwan
|
Initial
|
07 July 2022
|
07 July 2027
|
| View |
|
DRP-12241
|
Rosuvastatin (As Calcium)
|
Rostin 20
|
20 mg
|
Film Coated Tablet
|
-
|
Unison Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
30 June 2022
|
30 June 2027
|
| View |
|
DRP-12211
|
Ciprofloxacin (As Lactate)
|
Vonecip
|
2mg/mL (200 mg/100 mL)
|
Solution For Infusion (IV)
|
-
|
Aroma İlaç San. Ltd. Şti
|
Turkey
|
Initial
|
30 June 2022
|
30 June 2027
|
| View |
DR-XY48182_PI_01.pdf
|
DR-XY48182
|
Lenalidomide
|
Linadex 15
|
15mg
|
Capsule
|
Immunosuppressant
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
12 July 2022
|
12 July 2025
|
| View |
|
DRP-12262
|
Cefepime (as hydrochloride)
|
Saphipime
|
1 gram
|
Powder for Injection (I.V./I.M.)
|
Antibacterial (Cephalosporin)
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
06 July 2022
|
06 July 2027
|
| View |
|
DR-XY48157
|
Dabigatran etexilate (as mesilate)
|
Dabitrin 150
|
150 mg
|
Capsule
|
Antithrombotic Agent (Direct Thrombin Inhibitor)
|
Hetero Labs Limited (Unit III)
|
India
|
Initial (Variation)
|
14 March 2024
|
14 March 2029
|
| View |
|
DR-XY48158
|
Dabigatran etexilate (as mesilate)
|
Dabitrin 75
|
75 mg
|
Capsule
|
Antithrombotic Agent (Direct Thrombin Inhibitor)
|
Hetero Labs Limited (Unit III)
|
India
|
Initial (Variation)
|
14 March 2024
|
14 March 2029
|
| View |
|
DR-XY 48176
|
Lenalidomide
|
Linadex 25
|
25 mg
|
Capsule
|
Immunosuppressant
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
11 July 2022
|
11 July 2025
|
| View |
|
DRP-12271
|
Ciprofloxacin (as hydrochloride)
|
Ancipro-500
|
500 mg
|
Film-coated Tablet
|
Antibacterial (Quinolones)
|
Hiral Labs Limited
|
India
|
Initial
|
07 July 2022
|
07 July 2027
|
| View |
|
DRP-8481
|
Celecoxib
|
Rifoxib
|
200 mg
|
Capsule
|
Selective COX-2 Inhibitor
|
Lloyd Laboratores, Inc.
|
Philippines
|
Renewal
|
11 August 2024
|
01 December 2029
|
| View |
|
DRP-12313
|
Olanzapine
|
Salveo® ODT
|
10 mg
|
Orodispersible Tablet
|
Antipsychotic
|
Pharmathen SA
|
Greece
|
Initial
|
13 July 2022
|
13 July 2027
|
| View |
|
DRP-12232
|
Ascorbic Acid + Zinc
|
Florvit-C Plus
|
533.4mg (equivalent to 600mg Sodium Ascorbate)/10mg (equivalent to 27.45mg Zinc Sulfate Monohydrate)
|
Capsule
|
Vitamin/Mineral
|
Bauch Phils. Laboratories Inc.
|
Philippines
|
Initial (OTC][PCPR)
|
30 June 2022
|
30 June 2027
|
| View |
|
DR-XY48168
|
Ticagrelor
|
Gretor 60
|
60 mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
05 July 2022
|
05 July 2027
|
| View |
|
DR-XY48167
|
Ticagrelor
|
Gretor 90
|
90 mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
05 July 2022
|
05 July 2027
|
| View |
|
DRP-12227
|
Loratadine
|
None
|
5 mg
|
Chewable Tablet
|
Antihistamine
|
Maxtar Bio-Genics
|
India
|
Initial (OTC)
|
30 June 2022
|
30 June 2027
|
| View |
|
DRP-12279
|
Sitagliptin (as phosphate) + Metformin HCl
|
Metsaphtin-50/1000
|
50 mg/1g
|
Film-Coated Tablet
|
Blood Glucose Lowering Drug (Dipeptidyl Peptidase 4
Inhibitor/Biguanide)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
07 July 2022
|
07 July 2027
|
| View |
|
DR-XY48185
|
Anagrelide (as hydrochloride)
|
Anator
|
500 mcg
|
Capsule
|
Antineoplastic :
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
13 July 2022
|
13 July 2027
|
| View |
|
DRP-12314
|
Loperamide
|
Rexamide
|
10 mg
|
Capsule
|
Antimotility
|
Next Wave (India)
|
India
|
Initial (OTC)
|
13 July 2022
|
13 July 2027
|
| View |
|
DR-XY48169
|
Apixaban
|
None
|
2.5 mg
|
Film- Coated Tablet
|
Antithrombotic Agent (Direct Factor Xa Inhibitor)
|
Cadila Healthcare Limited
|
India
|
Initial
|
07 July 2022
|
07 July 2027
|
| View |
|
BR-1355
|
Diphtheria-Tetanus Vaccine (Adsorbed, Reduced
Antigen Content)
|
BE Td
|
Each dose (0.5 mL) contains: Diphtheria toxoid-2 Lf (>2 IU) Tetanus toxoid-8.8 Lf (>20 IU) Adsorbed on Aluminum Phosphate-> 1.5 mg Preservative: Thiomersal BP-0.01% w/v
|
Suspension for Injection (IM)
|
-
|
Biological E. Limited
|
India
|
Initial
|
17 June 2021
|
17 June 2026
|