| View |
|
DRP-13958
|
Colistimethate Sodium
|
Colium
|
2 Million I.U. (equivalent to 66. 67mg Colistion base)
|
Lyophilized Powder For Injection (I.V.)
|
-
|
United Biotech Pvt. Ltd.
|
India
|
Initial (Re-application)
|
25 May 2023
|
25 May 2028
|
| View |
|
DRP-13948
|
Dexmedetomidine (as hydrochloride)
|
DexmidoGet
|
100 mcg/ mL
|
Solution For Intravenous Infusion)
|
-
|
Swiss Parenterals Ltd. (Block-B)
|
India
|
Initial
|
23 May 2023
|
23 May 2028
|
| View |
|
DRP-13952
|
Mefenamic Acid
|
None
|
500 mg
|
Film-Coated Tablet
|
-
|
Medico Remedies Limited
|
India
|
Initial
|
24 May 2023
|
24 May 2025
|
| View |
|
HRP-611
|
Ethyl Alcohol
|
None
|
70%( v/v)
|
Topical Solution
|
-
|
Universal Robina Corporation
|
Philippines
|
Initial
|
24 May 2023
|
24 May 2028
|
| View |
|
DRP-13972
|
Rivaroxaban
|
Risaphxaban
|
15 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
26 May 2023
|
26 May 2028
|
| View |
|
DR-XY48750
|
Tenofovir disoproxil fumarate + Lamivudine
Efavirenz
|
Avonza
|
300mg/300mg/400mg
|
Film-Coated Tablet
|
-
|
Mylan Laboratories Limited.
|
India
|
Monitored Release (MR) (Re-application)
|
26 May 2023
|
26 May 2028
|
| View |
|
DRP-13977
|
Olanzapine
|
Lanzaph
|
10 mg
|
Orally Disintegrating Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
29 May 2023
|
29 May 2028
|
| View |
|
DRP-13959
|
Tranexamic Acid
|
Tranez
|
100 mg/mL (500 mg/5 mL)
|
Solution for Injection
(I.M./I.V.)
|
Antifibrinolytic (Amino Acid)
|
Makcur Laboratories Limited
|
India
|
Initial (Variation-turned-Initial)
|
24 September 2024
|
24 September 2029
|
| View |
|
DR-XY29748
|
Aluminum Hydroxide + Magnesium Hydroxide +
Simethicone
|
Kremil-S
|
178 mg/233 mg/30 mg
|
Chewable Tablet
|
-
|
UNILAB, Inc.
|
Philippines
|
Initial
|
24 May 2023
|
24 May 2028
|
| View |
|
DR-XY48749
|
Mometasone Furoate
|
Momevex
|
1mg/g 0.1% w/w
|
Cream
|
-
|
Yash Pharmaceuticals
|
India
|
Initial
|
26 May 2023
|
26 May 2028
|
| View |
|
DR-XY48722
|
Mupirocin
|
Muprivex
|
20MG/G (2% w/w)
|
Ointment
|
Antibacterial (Antibiotic for Topical Use)
|
Yash Pharmaceuticals
|
India
|
Initial (OTC) Correction]
|
02 February 2024
|
26 May 2028
|
| View |
|
DRP-13975
|
Ascorbic Acid + Zinc
|
Rapcvit Plus CT
|
250 mg (equivalent to 281.25 mg Sodium Ascorbate)/ 5 mg (equivalent to 35 mg Zinc Gluconate)
|
Chewable Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
29 May 2023
|
29 May 2028
|
| View |
|
DR-XY48751
|
Vildagliptin
|
Vildanorm
|
50 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
26 May 2023
|
26 May 2028
|
| View |
DR-XY48738_PI_01.pdf
|
DR-XY48738
|
Amoxicillin (as trihydrate)
|
Sitimox
|
500 mg
|
Capsule
|
-
|
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd
|
China
|
Initial (Re-Application)
|
22 May 2023
|
22 May 2028
|
| View |
|
DRP-13942
|
Sodium Valproate
|
None
|
200 mg/ 5 mL
|
Oral Solution
|
-
|
Novagen Healthcare Private Limited
|
India
|
Initial
|
23 May 2023
|
23 May 2028
|
| View |
|
DRP-14011
|
Ampicillin (as sodium)
|
Noldicin
|
500mg
|
Powder For Injection (IM/IV)
|
-
|
Swiss Parenterals Limited
|
India
|
Initial
|
05 June 2023
|
05 June 2028
|
| View |
|
DRP-13997
|
Pregabalin
|
Neurorite
|
75mg
|
Capsule
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
01 June 2023
|
01 June 2028
|
| View |
|
DRP-13984
|
Apixaban
|
Apixastal-2.5
|
2.5 mg
|
Film-Coated Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
31 May 2023
|
31 May 2028
|
| View |
|
DRP-13983
|
Apixaban
|
Apixastal-5
|
5 mg
|
Film-Coated Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
31 May 2023
|
31 May 2028
|
| View |
|
DRP-13986
|
Apixaban
|
Pixab
|
5 mg
|
Film-Coated Tablet
|
Antithrombotic agent (Direct factor Xa inhibitor)
|
Intas Pharmaceuticals Limited
|
India
|
Initial (Reconstruction)
|
12 February 2024
|
31 May 2028
|