| View |
|
DRP-13525
|
Clindamycin (As Hydrochloride)
|
Clindanova
|
300 mg
|
Capsule
|
-
|
Saga Lifesciences Limited
|
India
|
DRP-13525
|
06 March 2023
|
06 March 2028
|
| View |
|
DRP-13526
|
Etoricoxib
|
Etoxia 60
|
60mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
DRP-13526
|
06 March 2023
|
06 March 2028
|
| View |
|
DRP-13527
|
Etoricoxib
|
Etoxia 120
|
120mg
|
Film-Coated Tablets
|
-
|
Globela Pharma Private Limited
|
India
|
DRP-13527
|
06 March 2023
|
06 March 2028
|
| View |
|
DRP-13524
|
Gabapentin
|
Gabaknock
|
100 mg
|
Capsule
|
Antiepileptic
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
06 March 2023
|
06 March 2028
|
| View |
|
DRP-13505
|
Gentamicin (as Sulfate)
|
Gentrine
|
3 mg/mL (0.3% w/v)
|
Sterile Ophthalmic Solution
|
-
|
Indiana Ophthalmics
|
India
|
DRP-13505
|
28 February 2023
|
28 February 2028
|
| View |
|
DRP-13528
|
Vildagliptin
|
Vildatec
|
50 mg
|
Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
DRP-13528
|
06 March 2023
|
06 March 2028
|
| View |
|
DRP-13534
|
Lactated Ringer's Solution
|
One-Dex LR
|
Formulation:
Each 100 mL Solution contains:
Sodium Lactate (60%) solution 533 g
Equivalent to 320 g Sodium Lactate
Sodium Chloride 600 g
Potassium Chloride 40 g
Calcium Chloride 27 g
|
Solution For I.V. Infusion
|
-
|
Abaris Healthcare Pvt. Ltd.
|
India
|
DRP-13534
|
08 March 2023
|
08 March 2028
|
| View |
|
DRP-13493
|
Folic Acid
|
Medfocid
|
5 mg
|
Tablet
|
-
|
S Kant Healthcare Ltd.
|
India
|
DRP-13493
|
28 February 2023
|
28 February 2028
|
| View |
|
DRP-13503
|
Pemetrexed (As disodium)
|
Meditrexed-500
|
500mg
|
Lyophilized Powder for Injection (IV Infusion)
|
-
|
Shanghai Chemo Wanbang Biopharma Co., Ltd.
|
China
|
DRP-13503
|
28 February 2023
|
28 February 2028
|
| View |
|
DRP-13504
|
Pemetrexed(As disodium)
|
Meditrexed 100
|
100 mg
|
Lyophilized Powder for Injection (IV Infusion)
|
-
|
Shanghai Chemo Wanbang Biopharma Co., Ltd.
|
China
|
DRP-13504
|
28 February 2023
|
28 February 2028
|
| View |
|
DRP-13515
|
Gliclazide
|
Diaxid
|
80 mg
|
Tablet
|
-
|
Healer's Lab (Unit II)
|
India
|
DRP-13515
|
03 March 2023
|
03 March 2028
|
| View |
|
DRP-13518
|
Levetiracetam
|
Levexam
|
250 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
DRP-13518
|
03 March 2023
|
03 March 2028
|
| View |
|
DRP-13517
|
Levetiracetam
|
Levexam
|
500 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
DRP-13517
|
03 March 2023
|
03 March 2028
|
| View |
|
DRP-13521
|
Irbesartan
|
Irbeq 150
|
150mg
|
Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
DRP-13521
|
03 March 2023
|
03 March 2028
|
| View |
DR-XY48642_PI_01.pdf
|
DR-XY48642
|
Bendamustine Hydrochloride
|
Bendared
|
45 mg/mL
|
Concentrate for Solution for IV Infusion.
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
DR-XY48642
|
08 March 2023
|
08 March 2028
|
| View |
|
DRP-13519
|
Tamsulosin Hydrochloride
|
Tamsufar
|
400 mcg
|
Prolonged-Release Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
DRP-13519
|
03 March 2023
|
03 March 2028
|
| View |
|
DRP-13533
|
Lactulose
|
Dolac
|
10 g/15 mL (3.33 g/5 mL)
|
Oral Solution
|
-
|
Rhydburg Pharmaceuticals Limited
|
India
|
DRP-13533
|
08 March 2023
|
08 March 2028
|
| View |
|
DRP-13520
|
Irbesartan
|
Irbeq 300
|
300mg
|
Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
DRP-13520
|
03 March 2023
|
03 March 2028
|
| View |
|
DR-XY48641
|
Colecalciferol (Vitamin D)
|
None
|
400 IU
|
Softgel Capsule
|
-
|
Arizona Nutritional Supplements
|
United States of America
|
Initial (OTC)
|
07 March 2023
|
07 March 2028
|
| View |
|
DR-XY48638
|
Rivaroxaban
|
None
|
10 mg
|
Film-Coated Tablet
|
-
|
Beker Laboratories
|
Algeria
|
DR-XY48638
|
28 February 2023
|
28 February 2028
|