View |
|
DR-XY48786
|
Clotrimazole
|
Mno-Each
|
100mg
|
Vaginal Tablet
|
-
|
Akriti Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
29 June 2023
|
29 June 2028
|
View |
|
BR-1447
|
Rituximab
|
Acellbia
|
500 mg/50 mL (10 mg/mL)
|
Concentrate For Solution For Infusion (Iv)
|
-
|
Joint Stock Company BIOCAD
|
Russia
|
Initial
|
30 June 2023
|
30 June 2028
|
View |
|
DR-XY48792
|
Topiramate
|
Toramig 100
|
100 mg
|
Film Coated Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
30 June 2023
|
30 June 2028
|
View |
|
DR-XY48801
|
Candesartan cilexetil
|
Aiiracan 16
|
16mg
|
Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
30 June 2023
|
30 June 2028
|
View |
|
DR-XY48805
|
Esomeprazole (as magnesium trihydrate)
|
Esmazo;
|
40mg
|
Enteric-Coated Tablet
|
-
|
Lee Pharma Limited
|
India
|
Initial
|
30 June 2023
|
30 June 2025
|
View |
|
DRP-14150
|
Fluconazole
|
Fluzel
|
200 mg
|
Capsule
|
-
|
MAGBRO HEALTHCARE PVT. LTD.
|
INDIA
|
Initial
|
30 June 2023
|
30 June 2028
|
View |
|
DRP-14151
|
Fluconazole
|
Terizole
|
200 mg
|
Capsule
|
-
|
MAGBRO HEALTHCARE PVT. LTD.
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
View |
|
DRHR-2248
|
Menthol + Peppermint Oil
|
None
|
55.90 g/3.73 mL per 100 mL
|
Solution For Inhalation
|
-
|
Bertram (1958) Co., Ltd.
|
Thailand
|
Initial
|
29 June 2023
|
29 June 2028
|
View |
|
DRP-14165
|
Solifenacin succinate
|
Vesizen 5
|
5 mg
|
Film-Coated Tablet
|
Drugs for Urinary Frequency and Incontinence
|
Sun Pharma Laboratories Ltd.
|
India
|
Initial (Correction)
|
26 September 2024
|
07 July 2028
|
View |
|
DRP-8577
|
Budesonide
|
Budesma
|
200 mcg
|
Metered Dose Inhalation
|
Corticosteroid
|
Glenmark Pharmaceuticals Ltd.
|
India
|
Automatic Renewal
|
02 July 2023
|
27 December 2028
|
View |
|
DRP-4826-05
|
Escitalopram (As Oxalate)
|
Amantin
|
10 mg
|
Film-Coated Tablet
|
Antidepressant
|
Akums Drugs & Pharmaceutical Ltd. (Plant I - Solid Oral Dosage Facility)
|
India
|
Automatic Renewal
|
02 July 2023
|
16 October 2028
|
View |
|
DRP-4921-02
|
Sertraline (As Hydrochloride)
|
Sertragen
|
50 mg
|
Film-Coated Tablet
|
Antidepressant
|
Sydler Remedies Pvt. Ltd.
|
India
|
Automatic Renewal
|
22 June 2023
|
13 November 2028
|
View |
|
DR-XY48159
|
Ciprofloxacin
|
Ciclodin IV
|
2mg/mL (400mg/200mL)
|
Solution for IV Injection
|
Antibacterial (Fluoroquinolone)
|
HK inno.N Corporation
|
Korea
|
Initial (Reconstruction)
|
01 February 2024
|
28 June 2027
|
View |
|
DRP-12333-01
|
Diosmin + Hesperidin
|
VenoCare 1000
|
900mg/100mg
|
Tablet
|
-
|
Saga Lifesciences Limited
|
India
|
CLIDP Conversion
|
03 November 2022
|
20 July 2027
|
View |
|
DRP-14171
|
Ketoanalogues + Essential Amino Acids
|
Vipketo
|
Formulation:
Each Film-Coated Tablet contains:
Calcium-4-methyl-2-oxo-valerate
(a-ketoanalogue to leucine, calcium salt) 101 mg
Calcium-3-methyl-2-oxo-butyrate
(a-ketoanalogue to valine, calcium salt) 86 mg
Calcium-2-oxo-3-phenylproprionate
(a-ketoanalogue to phenylalanine, calcium salt) 68 mg
Calcium-3-methyl-2-oxo-valerate
(a-ketoanalogue to isoleucine, calcium salt) 67 mg
Calcium-DL-2-hydroxy-4-(methylthio)
(a-hydroxyanalogue to methionine, 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 Nutrition Therapy
|
4CARE LIFESCIENCE PVT. LTD.
|
India
|
Initial
|
14 July 2023
|
14 July 2028
|
View |
|
DRP-14180
|
Apixaban
|
Apixa
|
2.5 mg
|
Film Coated Tablet
|
-
|
Unison Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
14 July 2023
|
14 July 2028
|
View |
|
DRP-14179
|
Apixaban
|
Apixa 5
|
5 mg
|
Film Coated Tablet
|
-
|
Unison Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
14 July 2023
|
14 July 2028
|
View |
|
DR-XY48817
|
Zoledronic Acid (as monohydrate)
|
Sinresor
|
4 mg
|
Lyophilized Powder For Iv Infusion
|
-
|
Laboratorio Kemex S.A.
|
Argentina
|
Initial (Reapplication)
|
18 July 2023
|
18 July 2028
|
View |
|
DRP-14148
|
Citicoline (As Sodium)
|
Citcole
|
125mg/mL (500mg /4mL)
|
Solution For Injection (I.M./I.V.)
|
-
|
Cisen Pharmaceutical Co., Ltd.
|
China
|
Initial
|
05 July 2023
|
05 July 2028
|
View |
|
DRP-14164
|
Clindamycin (as phosphate)
|
None
|
150mg/mL
|
Solution For Injection
|
-
|
Samrudh Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
07 July 2023
|
07 July 2028
|