| View |
|
DRP-14066
|
Vildagliptin
|
Valstat
|
50mg
|
Tablet
|
-
|
Lee Pharma Limited
|
India
|
Initial
|
13 June 2023
|
13 June 2028
|
| View |
|
DRP-14076
|
Co-Amoxiclav
|
MoxCV 625
|
625 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin/Beta-lactamase inhibitor)
|
Sun Pharma Laboratories Ltd.
|
India
|
Initial (Correction)
|
05 June 2024
|
14 June 2028
|
| View |
|
HRP-614
|
Methyl Salicylate Menthol + Camphor
|
None
|
6.50 mL/ 0.75 g /0.25 g per 100 mL
|
Liniments
|
-
|
Shanne Herbal Manufacturing
|
Philippines
|
Initial
|
16 June 2023
|
16 June 2025
|
| View |
|
DRP-14073
|
Febuxostat
|
Uxenta
|
40mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited.
|
India
|
Initial
|
13 June 2023
|
13 June 2028
|
| View |
|
DRP-14074
|
Paracetamol
|
Azamol
|
500 mg
|
Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
14 June 2023
|
14 June 2028
|
| View |
|
DRP-14079
|
Xylometazoline hydrochloride
|
Xytasaph
|
500 mcg/mL (0.05% w/v)
|
Nasal Solution (Drops)
|
Nasal Drops Decongestant
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial [OTC]
|
16 June 2023
|
16 June 2028
|
| View |
|
DRP-14080
|
Xylometazoline hydrochloride
|
Xytasaph
|
1 mg/mL (0.10% w/v)
|
Nasal Drops
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial [OTC]
|
16 June 2023
|
16 June 2028
|
| View |
DR-XY48772_PI_01.pdf
|
DR-XY48772
|
Silodosin
|
Ureleve
|
4mg
|
Capsule
|
-
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
09 June 2023
|
09 June 2028
|
| View |
|
DRP-14095
|
Bimatoprost + Timolol Maleate
|
Timoptabim
|
300 mcg/5 mg per mL (0.03% w/v/0.5% w/v) Sterile
|
Ophthalmic Solution
|
Antiglaucoma (Prostaglandin Analogue and Beta
Blocking Agent Combination)
|
World Medicine Ilac Sanayi Ve Ticaret A.S.
|
Turkey
|
Initial
|
20 June 2023
|
20 June 2028
|
| View |
|
DRP-14094
|
Bimatoprost
|
Bimatop
|
300 mcg/mL (0.03% w/v)
|
Ophthalmic Solution
|
-
|
World Medicine Ilac Sanayi Ve Ticaret A.S.
|
Turkey
|
Initial
|
20 June 2023
|
20 June 2028
|
| View |
|
DRP-14093
|
Apixaban
|
None
|
2.5 mg
|
Film- Coated Tablet
|
Antithrombotic Agent (Direct Factor Xa Inhibitor)
|
Zydus Lifesciences Limited
|
India
|
Initial
|
20 June 2023
|
20 June 2028
|
| View |
|
DRP-14092
|
Apixaban
|
None
|
5 mg
|
Film- Coated Tablet
|
-
|
Zydus Lifesciences Limited
|
India
|
Initial
|
20 June 2023
|
20 June 2028
|
| View |
|
DRP-14098
|
Vildagliptin
|
Vildaxil
|
50mg
|
Tablet
|
Hypoglycemic Agent (Dipeptidyl Peptidase-4 [DPP-4]
Inhibitor)
|
Globela Pharma Private Limited
|
India
|
Initial
|
21 June 2023
|
21 June 2028
|
| View |
|
DRP-14090
|
Imatinib (as mesylate)
|
Imarem
|
100 mg
|
Film-Coated Tablet
|
-
|
Remedica Ltd..
|
Cyprus
|
Initial
|
20 June 2023
|
20 June 2028
|
| View |
DRP-14096_PI_01.pdf
|
DRP-14096
|
Clindamycin (as phosphate)
|
Afrenda
|
150mg/mL
|
Solution for Injection
|
Antibacterial (Lincosamide)
|
Makcur Laboratories Limited
|
India
|
Initial
|
20 June 2023
|
20 June 2028
|
| View |
|
DRP-14097
|
Potassium Chloride
|
Kalemsaph-INF2
|
40 mEq/20mL (2mEq/mL)
|
Solution for Injection
|
-
|
Althea Pharma Pvt. Ltd.
|
India
|
Initial
|
20 June 2023
|
20 June 2028
|
| View |
|
DRP-14088
|
Tobramycin (as sulfate) + Dexamethasone
(as sodium phosphate)
|
Abradex
|
3 mg/1 mg (0.3% 0.1% w/v) per mL
|
Sterile Ophthalmic
Suspension (Eye Drops)
|
Antibacterial (Aminoglycoside)/Corticosteroid
|
Makcur Laboratories Limited
|
India
|
Initial
|
20 June 2023
|
20 June 2028
|
| View |
|
DRP-14089
|
Imatinib (as mesylate)
|
Imarem
|
400 mg
|
Film-Coated Tablet
|
Antineoplastic
|
Remedica Ltd.
|
Cyprus
|
Initial
|
20 June 2023
|
20 June 2028
|
| View |
|
DRP-14087
|
Tranexamic Acid
|
Texakind
|
100 mg/mL (500 mg/5 mL)
|
Solution for Injection
(IM/IV)
|
-
|
Mankind Pharma Limited (Unit-I)
|
India
|
Initial
|
20 June 2023
|
20 June 2028
|
| View |
|
DRP-14091
|
Metformin Hydrochloride
|
Formet
|
500 mg
|
Film-Coated Tablet
|
Oral Hypoglycemic
|
Mercury Laboratories Ltd.
|
India
|
Initial
|
20 June 2023
|
20 June 2028
|