| View |
|
DRP-14608
|
Aciclovir
|
Virofred
|
50 mg/g (5% w/w)
|
Ointment
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
27 October 2023
|
27 October 2028
|
| View |
|
DRP-14599
|
Hydralazine hydrochloride
|
Hydralex
|
20 mg/mL
|
Solution for Injection (IM/IV)
|
-
|
Farbe Firma Pvt. Ltd.
|
India
|
Initial
|
25 October 2023
|
25 October 2028
|
| View |
|
DRP-14606
|
Apixaban
|
Apixar
|
5 mg
|
Film-Coated Tablet
|
-
|
Baroque Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
27 October 2023
|
27 October 2028
|
| View |
DR-XY48903_PI_01.pdf
|
DR-XY48903
|
Asciminib (as hydrochloride)
|
Bacrelba
|
20 mg
|
Film-Coated Tablet
|
-
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
19 October 2023
|
19 October 2028
|
| View |
DR-XY48902_PI_01.pdf
|
DR-XY48902
|
Asciminib (as hydrochloride)
|
Bacrelba
|
40 mg
|
Film-Coated Tablet
|
-
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
19 October 2023
|
19 October 2028
|
| View |
|
DRP-14601
|
Amlodipine (as besilate)
|
Madovin
|
10 mg
|
Film-Coated Tablet
|
-
|
The Madras Pharmaceuticals
|
India
|
Initial
|
26 October 2023
|
26 October 2028
|
| View |
|
DR-XY48905
|
Ranitidine (as hydrochloride)
|
Ranigerd
|
25 mg/mL (50 mg/2 mL)
|
Solution for Injection (I.M./I.V.)
|
-
|
Zee Laboratories Limited
|
India
|
Initial
|
20 October 2023
|
20 October 2028
|
| View |
|
DRP-14600
|
Apixaban
|
None
|
5 mg
|
Film-Coated Tablet
|
-
|
Natco Pharma Limited Pharma Division
(Unit IV and V)
|
India
|
Initial
|
25 October 2023
|
25 October 2028
|
| View |
|
DRP-14586
|
Sildenafil (as citrate)
|
None
|
25 mg
|
Film-Coated Tablet
|
-
|
Diamond Laboratories Inc.
|
Philippines
|
Initial
|
19 October 2023
|
19 October 2028
|
| View |
|
DRP-14574
|
Tranexamic Acid
|
Tranexsaph
|
500 mg
|
Capsule
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
18 October 2023
|
18 October 2028
|
| View |
|
DRP-14513
|
Tamsulosin hydrochloride
|
Susaphtam-400
|
400 mcg
|
Prolonged Release Capsule
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
18 October 2023
|
18 October 2028
|
| View |
DR-XY48906_PI_01.pdf
|
DR-XY48906
|
Palbociclib
|
Ibrance
|
75 mg
|
Film-Coated Tablet
|
-
|
Pfizer Manufacturing Deutschland GmbH
|
Germany
|
Monitored Release
|
20 October 2023
|
20 October 2028
|
| View |
DR-XY48907_PI_01.pdf
|
DR-XY48907
|
Palbociclib
|
Ibrance
|
100 mg
|
Film-Coated Tablet
|
-
|
Pfizer Manufacturing Deutschland GmbH
|
Germany
|
Monitored Release (MR)
|
20 October 2023
|
20 October 2028
|
| View |
DR-XY48908_PI_01.pdf
|
DR-XY48908
|
Palbociclib
|
Ibrance
|
125 mg
|
Film-Coated Tablet
|
-
|
Pfizer Manufacturing Deutschland GmbH
|
Germany
|
Monitored Release (MR)
|
20 October 2023
|
20 October 2028
|
| View |
|
DRP-14587
|
Clotrimazole
|
Akrizol
|
10 mg/g (1%w/w)
|
Topical Cream
|
-
|
Akriti Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
19 October 2023
|
19 October 2028
|
| View |
|
DRP-14541
|
Diosmin Hesperidin
|
Venotion
|
450 mg / 50 mg
|
Film-Coated Tablet
|
-
|
Mepro Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
19 October 2023
|
19 October 2028
|
| View |
|
DRP-14540
|
Diosmin Hesperidin
|
None
|
450 mg/50 mg
|
Film-Coated Tablet
|
-
|
Mepro Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
19 October 2023
|
19 October 2028
|
| View |
|
DRP-14593
|
Terbinafine (as hydrochloride)
|
Terboxor
|
250 mg
|
Film-Coated Tablet
|
-
|
BDA Healthcare Pvt. Ltd.
|
India
|
Initial
|
20 October 2023
|
20 October 2028
|
| View |
|
DR-XY48904
|
Dapsone
|
None
|
75 mg/g (7.5% w/w)
|
Topical Gel
|
-
|
Encube Ethicals Pvt. Ltd.
|
India
|
Monitored Release
|
20 October 2023
|
20 October 2028
|
| View |
|
DRP-14619
|
Fexofenadine hydrochloride
|
Histafen
|
120 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
03 November 2023
|
03 November 2028
|