| View |
|
DRP-12022-01
|
Fluconazole
|
Mycozole IV
|
2 mg/mL (200 mg/ 100 mL)
|
Solution for Intravenous Infusion
|
-
|
Hebei Tiancheng Pharmaceutical Co., Ltd
|
China
|
CLIDP Conversion
|
22 August 2022
|
30 March 2027
|
| View |
|
DR-XY47568
|
Ticagrelor
|
None
|
60 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Monitored Release
|
29 November 2021
|
29 November 2024
|
| View |
|
DRP-12882
|
Piracetam
|
Saphcetam-400
|
400 mg
|
Capsule
|
Nootropic (Other Psychostimulant and Nootropic)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
24 October 2022
|
24 October 2027
|
| View |
|
DRP-12879
|
Ketoanalogues + Essential Amino Acids
|
Ketonol
|
Formulation: Each film-coated tablet contains: a-ketoleucine calcium salt-101 mg a-ketovaline calcium salt-86 mg a-ketophenylalanine calcium salt-68 mg a-ketoisoleucine calcium salt-67 mg a-hydroxymethionine calcium salt-59 mg
L-lysine acetate-105 mg L-threonine-53 mg L-histidine-38 mg L-tyrosine-30 mg L-tryptophan- 23 mg
|
Film-Coated Tablet
|
Renal Nutritional Therapy
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial (Re-application)
|
25 October 2022
|
25 October 2027
|
| View |
|
DR-XY48424
|
Pregabalin
|
Pregeb 50
|
50 mg
|
Capsule
|
Antiepileptic
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DRP-12845
|
Sitagliptin (as phosphate monohydrate)
|
Volrea
|
100mg
|
Film-Coated Tablet
|
Dipeptidyl peptidase 4 (DPP-4) inhibitor
|
Globela Pharma Private Limited
|
India
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DRP-12871
|
Progesterone
|
Exprogest
|
100mg
|
Vaginal Soft Gel Capsule
|
-
|
Laboratorios Leon Farma SA
|
Spain
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DRP-12867
|
Progesterone
|
Exprogest
|
200mg
|
Vaginal Soft Gel Capsule
|
-
|
Laboratorios Leon Farma SA
|
Spain
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DRP-12886
|
Bupivacaine Hydrochloride
|
Anesticaine
|
5 mg/mL (0.5% w/v)
|
Solution for Injection (for Peripheral Nerve Block, Caudal Block, and Lumbar Epidural Block)
|
Local Anesthetic (Amide)
|
HBM Pharma S.R.O.
|
Slovak Republic
|
Initial
|
25 October 2022
|
25 October 2027
|
| View |
|
DRP-12880
|
Timolol (As Maleate)
|
Tomolol
|
5 mg per mL
|
Ophthalmic Solution
|
Antiglaucoma preparation and Miotic (Beta Blocking Agent)
|
Joint Stock Company "Farmak"
|
Ukraine
|
Initial
|
24 October 2022
|
24 October 2027
|
| View |
|
DRP-12881
|
Sitagliptin (as phosphate) + Metformin Hydrochloride
|
Sitanova Plus 50/500
|
50 mg/500 mg
|
Film-Coated Tablet
|
Antidiabetic Agent (Dipeptidyl peptidase 4 (DPP-4) inhibitor/Biguanide)
|
Eskayef Pharmaceuticals Limited
|
Bangladesh
|
Initial
|
24 October 2022
|
24 October 2027
|
| View |
|
DR-XY48430
|
5% Dextrose in Lactated Ringer's Solution
|
None
|
Formulation: Each 100 mL contains: Anhydrous Dextrose.... ............5g Sodium chloride..................600 mg
Sodium lactate.............................310 mg Potassium chloride..........................30 mg Calcium chloride (dihydrate)...........20 mg
|
Solution for Intravenous Infusion
|
Electrolyte Replenisher
|
Shijiazhuang No.4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DR-XY48429
|
5% Dextrose in Lactated Ringer's Solution
|
None
|
1000mL
|
Solution for Intravenous Infusion
|
Electrolyte Replenisher
|
Shijiazhuang No.4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DRP-12869
|
0.9% Sodium Chloride
|
NS
|
9 mg/mL (0.9% w/v)
|
Solution for Intravenous Infusion
|
Electrolyte Replenisher
|
AXA Parenterals Limited
|
India
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DRP-12868
|
Amoxicillin (as trihydrate)
|
Moxylor
|
250 mg / 5 mL
|
Powder for Oral Suspension (Strawberry Flavor)
|
Antibacterial (Penicillin)
|
Diamond Laboratories Inc.
|
Philippines
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DRP-12872
|
Gefitinib
|
None
|
250 mg
|
Film-Coated Tablet
|
Antineoplastic (Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor)
|
Natco Pharma Limited - Pharma Division (Unit IV and V)
|
India
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DRP-12864
|
Glimepiride
|
Dianov
|
2 mg
|
Tablet
|
Oral Hypoglycemic Agent
|
Ratnamani Healthacare Pvt. Ltd.
|
India
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DRP-12865
|
Amoxicillin(As Trihydrate)
|
Moxinova-250
|
250 mg/5mL
|
Powder For Oral Suspension (Pineapple flavor)
|
-
|
Yeluri Formulations Pvt Ltd.
|
India
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DRP-12863
|
Amoxicillin(As Trihydrate)
|
Moxinova-125
|
125 mg / 5 mL
|
Powder For Oral Suspension (Pineapple flavor)
|
Antibacterial (Penicillin)
|
Yeluri Formulations Pvt Ltd.
|
India
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DR-XY48423
|
Thiamine Hydrochloride (Vitamin B1) +
Pyridoxine Hydrochloride (Vitamin B6) +
Cyanocobalamin (Vitamin B12)
|
Faranerv-B
|
100 mg/100 mg/1 mg per 3 mL
|
Solution for Injection (IM/IV)
|
Vitamins
|
Scott-Edil Pharmacia Limited
|
India
|
Initial
|
25 October 2022
|
25 October 2027
|