View |
|
DR-XY23416
|
Meropenem (As Trihydrate)
|
Meronem
|
1 g
|
Powder For Injection (I.V.)
|
-
|
ACS Dobfar S.P.A.
|
Italy
|
Automatic Renewal
|
30 March 2021
|
10 February 2026
|
View |
DRP-14198_PI_01.pdf
|
DRP-14198
|
Febuxostat
|
Febuxorin
|
40 mg
|
Film-Coated Tablet
|
-
|
Gracure Pharmaceutical Ltd.
|
India
|
Initial (Correction)
|
23 August 2023
|
18 July 2028
|
View |
BR-1390_PI_01 NO RX SYMBOL.pdf
|
BR-1390
|
Romosozumab
|
Evenity
|
105 mg/ 1.17 mL
|
Solution for Injection (SC)
|
Drugs affecting bone structure and mineralization
|
Patheon Italia S.p.A
|
Italy
|
Monitored Release
|
29 March 2022
|
29 March 2025
|
View |
|
BR-1449
|
Human Placental Extract
|
Laennec
|
112 mg/2 mL
|
Solution for Injection (I.M./S.C.)
|
-
|
Japan Bio Products Co., Ltd. (L'Atelier Fujimitsu)
|
Japan
|
Monitored Release (Reapplication)
|
02 October 2023
|
02 October 2028
|
View |
|
DRP-14527
|
Telmisartan/Hydrochlorothiazide
|
Telmirx-HCTZ
|
40mg/12.5mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
02 October 2023
|
02 October 2028
|
View |
|
DRP-14526
|
Telmisartan/Hydrochlorothiazide
|
Telmirx-HCTZ
|
80mg/12.5mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
02 October 2023
|
02 October 2028
|
View |
|
DRP-14524
|
Dopamine Hydrochloride
|
Dopetron
|
40mg/mL (200mg/5mL)
|
Solution For Injection (I.V.)
|
-
|
Farbe Firma
|
India
|
Initial
|
02 October 2023
|
02 October 2028
|
View |
|
DRP-14525
|
Telmisartan+Hydrochlorothiazide
|
Telmirx-HCTZ
|
80mg/25mg
|
Film Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
02 October 2023
|
02 October 2028
|
View |
|
DRHR-2299
|
Ethyl Alcohol
|
Casino - Active
|
70 % (v/v)
|
Topical Solution
|
-
|
Sarvotham Urja Pvt. Ltd.
|
India
|
Initial
|
10 October 2023
|
10 October 2025
|
View |
|
DRMO-97
|
Medical Grade Oxygen
|
None
|
NONE
|
None
|
-
|
Genoox Air Specialist Inc.
|
Philippines
|
Initial
|
10 October 2023
|
10 October 2028
|
View |
|
DRP-14516
|
Mupirocin
|
Mupiwell
|
20 mg/g (2% w/w)
|
Topical Ointment
|
-
|
Hubei Humanwell Chengtain Pharmaceuticals Co., Ltd.
|
China
|
Initial (OTC]
|
02 October 2023
|
02 October 2028
|
View |
|
DR-XY48891
|
Ascorbic Acid
|
None
|
250 mg/mL (500 mg/2 mL)
|
Solution for Injection
(IM/IV)
|
-
|
Anhui Hongye Pharmaceutical Co., Ltd.
|
China
|
Initial
|
02 October 2023
|
02 October 2028
|
View |
|
DR-XY48890
|
Ascorbic Acid
|
Saicorvic
|
250 mg/mL (500 mg/2 mL)
|
Solution for Injection
(IM/IV)
|
-
|
Anhui Hongye Pharmaceutical Co., Ltd.
|
China
|
Initial
|
02 October 2023
|
02 October 2028
|
View |
|
DRP-14303
|
Cefixime
|
Ultraxime
|
20 mg per mL
|
Granules For Suspension (Drops)
|
-
|
Asian Antibiotics, Inc.
|
Philippines
|
Initial (Variation)
|
29 September 2023
|
29 September 2028
|
View |
|
DRP-14528
|
Paracetamol
|
Uetamol-IV
|
10 mg/mL (200 mg/20 mL); (500 mg/50 mL); (1g/100 mL)
|
Solution for Injection (I.V. Infusion)
|
-
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
02 October 2023
|
02 October 2028
|
View |
|
DRP-14529
|
Rabeprazole Sodium
|
Rabesky-20
|
20mg
|
Powder for Injection (I.V. Infusion)
|
-
|
Skymap Healthcare Pvt. Ltd.
|
India
|
Initial
|
02 October 2023
|
02 October 2028
|
View |
|
DR-XY48898
|
Sonidegib (as phosphate)
|
Odomzo
|
200 mg
|
Capsule
|
Antineoplastic Agent (Hedgehog Pathway Inhibitor)
|
Patheon Inc.
|
Canada
|
Monitored Release (Reconstruction)
|
31 July 2024
|
05 October 2028
|
View |
|
DR-XY48899
|
Co Amoxiclav
|
Claxon
|
156.25 mg/5 mL
|
Powder for Oral Suspension
|
-
|
Medopharm Private Limited
|
India
|
Initial
|
16 October 2023
|
05 October 2028
|
View |
|
DRP-14530
|
Co-Amoxiclav
|
Axalav
|
1.2 g
|
Powder for Injection (I.V.)
|
-
|
UNI MEDICOLABS INC.
|
India
|
Initial
|
03 October 2023
|
03 October 2028
|
View |
|
DRP-14545
|
Mupirocin
|
Pelisafe
|
20mg/g (2% w/w)
|
Topical Ointment
|
-
|
Helios Pharmaceuticals
|
India
|
Initial
|
10 October 2023
|
10 October 2028
|