| View |
|
DRP-12161
|
Tigecycline
|
Saphcycline
|
50 mg
|
Lyophilized Powder for Injection (I.V. Infusion)
|
Antibacterial (Tetracycline)
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
29 June 2022
|
29 June 2027
|
| View |
|
DR-XY48132
|
Tadalafil + Tamsulosin Hydrochloride
|
Duactam
|
5mg/400mcg
|
Capsule
|
Alpha-Adrenorecptor Antagonist
|
Ajanta Pharma Limited
|
India
|
Monitored Release (Re-application)
|
23 June 2022
|
23 June 2027
|
| View |
|
DRP-10725-03
|
Cetirizine Hydrochloride
|
Irizine-10
|
10 mg
|
Film-Coated Tablet
|
Antihistamine (Piperazine Derivative)
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial (Re-application)
|
30 June 2022
|
15 November 2026
|
| View |
|
DRP-12208
|
Risperidone
|
Amidrex OD-1
|
1 mg
|
Orally Disintegrating Tablet
|
Antipsychotic
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial (Re-application)
|
29 June 2022
|
29 June 2027
|
| View |
|
DRP-12207
|
Risperidone
|
Amidrex Od-2
|
2 mg
|
Orally Disintegrating Tablet
|
Antipsychotic
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial (Re-application)
|
29 June 2022
|
29 June 2027
|
| View |
|
DRP-12176
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Sporasul
|
500 mg / 250 mg
|
Powder For Solution For I.M/I.V
|
-
|
Egyptian International Pharmaceutical Industries Co.
(EIPICO)
|
Egypt
|
Initial
|
24 June 2022
|
24 June 2027
|
| View |
|
DRP-12175
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Sporasul
|
1 g/500 mg
|
Powder For Injection (I.M/I.V)
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Egyptian International Pharmaceutical Industries Co.
(EIPICO)
|
Egypt
|
Initial
|
24 June 2022
|
24 June 2027
|
| View |
|
DRP-12148
|
Olopatadine (as hydrochloride)
|
Patolop
|
1 mg/mL (0.1% w/v)
|
Ophthalmic Solution (Eye Drops)
|
Antihistamine
|
World Medicine İlaç Sanayi Ve Ticaret A.Ş
|
Turkey
|
Initial
|
23 June 2022
|
23 June 2027
|
| View |
|
DRP-12199
|
Vildagliptin
|
Vildaxil
|
50 mg
|
Tablet
|
Blood Glucose Lowering Drug [Dipeptidyl Peptidase
4 (DPP-4) Inhibitor]
|
Globela Pharma Private Limited
|
India
|
Initial
|
29 June 2022
|
29 June 2027
|
| View |
|
DR-XY48122
|
Ertapenem (as sodium)
|
Ertapen
|
1 g
|
Lyophilized Powder for Injection (I.V.)
|
Antibacterial (Carbapenem)
|
Savior Lifetec Corporation (Tainan Branch Injection Plant)
|
Taiwan
|
Initial
|
21 June 2022
|
21 June 2027
|
| View |
|
HRP-528
|
Chlorhexidine
|
Steri-Q Surgical Cleanser
|
4 g (4%w/v) per 100 mL
|
Topical Solution
|
Antiseptic
|
Kohl Industries Corporatio
|
Philippines
|
Initial (HR)
|
27 June 2022
|
27 June 2027
|
| View |
|
DRP-12171
|
Fusidic Acid
|
Fusiburg
|
20 mg/g (2% w/w)
|
Topical Cream
|
Antibacterial
|
Rhydburg Pharmaceuticals Limited
|
India
|
Initial (OTC)
|
23 June 2022
|
23 June 2027
|
| View |
|
DRP-12184
|
Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate
|
Avisaph
|
500 mg/ 213 mg/ 325 mg per 10 mL
|
Oral Suspension
|
Antacid
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial (OTC)
|
27 June 2022
|
21 June 2027
|
| View |
|
DRP-12189
|
Ketoconazole
|
Krenazol
|
20 mg/g (2% w/w)
|
Cream
|
Antifungal
|
Kremoint Pharma Pvt. Ltd.
|
India
|
Initial (OTC)
|
28 June 2022
|
28 June 2027
|
| View |
|
DRP-12192
|
Co-Amoxiclav
|
Clavubac
|
457 mg/5 mL
|
Powder for Oral Suspension
|
Antibacterial (Penicillin)
|
J.M. Tolmann Laboratories, Inc.
|
Philippines
|
Initial (Correction)
|
02 September 2022
|
02 September 2027
|
| View |
|
DRP-12187
|
Capecitabine
|
Apcibine
|
500 mg
|
Film-Coated Tablet
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Initial
|
29 June 2022
|
29 June 2027
|
| View |
|
DRP-12169
|
Febuxostat
|
Atenurix
|
40mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
28 June 2022
|
28 June 2027
|
| View |
|
DRP-12170
|
Febuxostat
|
Atenurix
|
80mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
28 June 2022
|
28 June 2027
|
| View |
|
DRP-12067
|
Trimetazidine (as hydrochloride)
|
Vastazine
|
20mg
|
Film Coated Tablet
|
Anti-angina (Fatty acid oxidation (pFOX) inhibitor)
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Automatic Renewal (E-AR)
|
23 February 2024
|
22 June 2029
|
| View |
|
DR-XY48138
|
Propacetamol Hydrochloride
|
Febrex
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
Aju Pharm. Co., Ltd.
|
Korea
|
Initial
|
27 June 2022
|
27 June 2027
|