| View |
|
DRP-12020
|
Entecavir
|
Tecavir 1 mg
|
1mg
|
Film-Coated Tablet
|
Antiviral
|
Hetero Labs Limited
|
India
|
Initial (Correction)
|
30 June 2022
|
31 May 2027
|
| View |
|
DRP-12021
|
Entecavir
|
Tecavir 0.5 mg
|
500 mcg
|
Film-Coated Tablet
|
Antiviral
|
Hetero Labs Limited
|
India
|
Initial (Correction)
|
31 August 2022
|
31 May 2027
|
| View |
|
DR-XY48103
|
Clotrimazole + Betamethasone (as dipropionate) +
Gentamicin (as sulfate)
|
Tribact
|
0 mg/ 1 mg/ 500 mcg (1%/ 0.1%/ 0.05% w/w)
|
Cream
|
Antifungal/ Corticosteroid/ Antibacterial
(Aminoglycoside)
|
Front Pharmaceutical PLC
|
China
|
Initial
|
10 June 2022
|
10 June 2027
|
| View |
|
DR-XY38425
|
Vancomycin (as Hydrochloride)
|
Vancom
|
1g
|
Powder for Injection (IV)
|
Antibacterial (Glycopeptide)
|
2 World Laboratories
|
India
|
Renewal
|
14 June 2022
|
25 August 2025
|
| View |
|
DRP-12094
|
Betahistine Dihydrochloride
|
None
|
24 mg
|
Tablet
|
Antivertigo
|
Lifesquare Laboratories Inc.
|
Philippines
|
Initial
|
10 June 2022
|
10 June 2027
|
| View |
|
DRP-12096
|
Betahistine Dihydrochloride
|
None
|
8mg Tablet
|
Tablet
|
Antivertigo
|
Lifesquare Laboratories Inc.
|
Philippines
|
Initial
|
10 June 2022
|
10 June 2027
|
| View |
|
DRP-12095
|
Betahistine Dihydrochloride
|
None
|
16 mg
|
Tablet
|
Antivertigo
|
Lifesquare Laboratories Inc.
|
Philippines
|
Initial
|
10 June 2022
|
10 June 2027
|
| View |
|
DRP-12116
|
Betahistine Dihydrochloride
|
Betahisdin
|
24 mg
|
Tablet
|
Antivertigo
|
Lifesquare Laboratories Inc.
|
Philippines
|
Initial
|
13 June 2022
|
13 June 2027
|
| View |
|
DRP-12114
|
Betahistine Dihydrochloride
|
Betahisdin
|
16 mg
|
Tablet
|
Antivertigo
|
Lifesquare Laboratories Inc.
|
Philippines
|
Initial
|
13 June 2022
|
13 June 2027
|
| View |
|
DRP-12115
|
Betahistine Dihydrochloride
|
Betahisdin
|
8 mg
|
Tablet
|
Antivertigo
|
Lifesquare Laboratories Inc.
|
Philippines
|
Initial
|
13 June 2022
|
13 June 2027
|
| View |
|
THPR-59
|
Valeriana wallichii DC. (Indian Valerian) Rhizome
|
None
|
250 mg
|
Capsule
|
Traditionally-Used Herbal Product: Helps
promoting restful sleep and maintain normal sleep.
|
The Himalaya Drug Company
|
India
|
Initial
|
10 June 2022
|
10 June 2027
|
| View |
|
DRP-12073
|
Clotrimazole
|
None
|
200 mg
|
Vaginal Suppository
|
Antifungal (Imidazole Dreivative)
|
Bliss GVS Pharma Ltd.
|
India
|
Initial
|
07 June 2022
|
07 June 2027
|
| View |
|
DRP-12052
|
Azacitidine
|
Azacord
|
100mg
|
Lyophilized Powder For Injection (IV/SC)
|
Antineoplastic Agent (Pyrimidine analogues)
|
Intas Pharmaceuticals Limited
|
India
|
Monitored Release (MR)
|
03 June 2022
|
03 June 2027
|
| View |
|
DR-XY48092
|
Lisinopril (as dihydrate)
|
Huanopril
|
10mg
|
Tablet
|
Angiotensin-converting Enzyme (ACE) Inhibitor
|
Zhejiang Huahai Pharmaceutical Co., Ltd.
|
China
|
Initial
|
06 June 2022
|
06 June 2027
|
| View |
|
DRP-12036
|
Decitabine
|
Decicord
|
50mg
|
Lyophilized Powder for Infusion (IV)
|
Antineoplastic
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
02 June 2022
|
02 June 2027
|
| View |
|
DR-XY48093
|
Clindamycin (As Phosphate)
|
Tidact
|
10 mg/g
|
Gel
|
Anti-acne
|
Y.S.P Industries (M) SDN. BHD
|
Malaysia
|
Initial (Correction)
|
02 September 2022
|
02 September 2027
|
| View |
|
DR-XY48117
|
Tranexamic Acid
|
Tafixyl
|
500 mg
|
Film-Coated Tablet
|
Antifibrinolytic
|
Labiana Pharmaceuticals, S.L.U
|
Spain
|
Initial
|
17 June 2022
|
17 June 2027
|
| View |
|
DR-XY48070
|
Avanafil
|
Spedra
|
100 mg
|
Tablet
|
Phosphodiesterase-5 Inhibitor
|
Sanofi Winthrop Industrie
|
France
|
Monitored Release
|
07 June 2022
|
07 June 2027
|
| View |
|
DR-XY48069
|
Avanafil
|
Spedra
|
200 mg
|
Tablet
|
-
|
Sanofi Winthrop Industrie
|
France
|
Monitored Release
|
07 June 2022
|
07 June 2027
|
| View |
|
DR-XY44090
|
Meropenem (As Trihydrate)
|
Sitipenam
|
1g
|
Powder For Injection (I.V.)
|
-
|
Intracin Pharmaceuticals Pvt. Ltd.
|
India
|
Initial (from Monitored Release)
|
07 June 2022
|
22 January 2025
|