| View |
|
DRP-8558
|
Ceftazidime
|
Aerum
|
1g
|
Powder For Injection (IM/IV)
|
Antibacterial (Cephalosporins)
|
Sinopharm Zhijun (Shenzhen) Pharmaceutical Co., Ltd.
|
China
|
Renewal
|
12 October 2024
|
10 November 2029
|
| View |
|
DRP-13721
|
Cetirizine (as Dihydrochloride) + Phenylephrine.
Hydrochloride
|
Saphezine
|
5mg/5mg per 5mL
|
Syrup (Orange Flavor)
|
-
|
Azine Healthcare Pvt. Ltd
|
India
|
Initial [OTC]
|
04 April 2023
|
04 April 2028
|
| View |
|
DRP-13720
|
Paracetamol + Phenylephrine hydrochloride +
Chlorphenamine maleate
|
Saphtran
|
125mg/ 2.5mg/ 500 mcg per 5 mL
|
Oral Suspension (Strawberry Flavor)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial [OTC]
|
04 April 2023
|
04 April 2028
|
| View |
|
DRP-13734
|
Docetaxel trihydrate
|
Unidocet-80
|
40 mg/mL (80 mg/2 mL)
|
Concentrate Solution for IV
|
-
|
Admac Lifesciences
|
India
|
Initial
|
03 April 2023
|
03 April 2028
|
| View |
DR-XY48674_PI_01.pdf
|
DR-XY48674
|
Ibrutinib
|
Imbruvica
|
420 mg
|
Film-Coated Tablet
|
Antineoplastic Agent (Protein Kinase Inhibitor)
|
Cilag AG
|
Switzerland
|
Monitored Release (Correction)
|
28 September 2023
|
30 March 2028
|
| View |
DR-XY48675_PI_01.pdf
|
DR-XY48675
|
Ibrutinib
|
Imbruvica
|
140 mg
|
Film-Coated Tablet
|
Antineoplastic Agent (Protein Kinase Inhibitor)
|
Cilag AG
|
Switzerland
|
Monitored Release (Correction)
|
28 September 2023
|
30 March 2028
|
| View |
|
DRHR-2232
|
Menthol + Camphor + Borneol + Eucalyptus Oil
|
None
|
420 mg/164 mg /61 mg /85 mL per mL
|
Inhaler
|
-
|
Gold Mints Products Co., Ltd.
|
Thailand
|
Initial
|
30 March 2023
|
30 March 2028
|
| View |
|
DR-XY48681
|
Tadalafil
|
None
|
20 mg
|
Orodispersible Film
|
-
|
Zim Laboratories Limited
|
India
|
Monitored Release
|
30 March 2023
|
30 March 2028
|
| View |
|
DR-XY48682
|
Tadalafil
|
None
|
10 mg
|
Orodispersible Film
|
-
|
Zim Laboratories Limited
|
India
|
Monitored Release
|
30 March 2023
|
30 March 2028
|
| View |
|
DR-XY48683
|
Tadalafil
|
Thafil 10
|
10mg
|
Orodispersible Film
|
-
|
Zim Laboratories Limited
|
India
|
Monitored Release
|
30 March 2023
|
30 March 2028
|
| View |
|
DRP-13733
|
Meropenem
|
Merobest 1000
|
1 g
|
Powder for Injection (I.V.)
|
-
|
Mason Pharma
|
India
|
Initial
|
03 April 2023
|
03 April 2028
|
| View |
|
DRP-13723
|
Metformin Hydrochloride
|
Metforze
|
500 mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
31 March 2023
|
31 March 2028
|
| View |
|
DRP-13749
|
Itraconazole
|
Candiforce-100
|
100 mg
|
Capsule
|
-
|
RA Chem Pharma Limited
|
India
|
Initial
|
05 April 2023
|
05 April 2028
|
| View |
|
DRP-13750
|
Itraconazole
|
None
|
100 mg
|
Capsule
|
-
|
RA Chem Pharma Limited
|
India
|
Initial
|
05 April 2023
|
05 April 2028
|
| View |
|
DRP-13744
|
Isotretinoin
|
Isonoin 10
|
10 mg
|
Softgel Capsule
|
Anti-acne (Retinoid)
|
Gelnova Laboratories (India) Pvt. Ltd.
|
India
|
Initial
|
04 April 2023
|
04 April 2028
|
| View |
|
DRP-13743
|
Isotretinoin
|
Isonoin 20
|
20mg
|
Softgel Capsule
|
-
|
Gelnova Laboratories (India) Pvt. Ltd.
|
India
|
Initial
|
04 April 2023
|
04 April 2028
|
| View |
|
DRP-13713
|
Losartan Potassium + Hydrochlorothiazide
|
Biozart Plus 25
|
100 mg/25 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
30 March 2023
|
30 March 2028
|
| View |
|
DRP-13751
|
Ibandronic Acid (as sodium monohydrate)
|
Ibandoprim
|
150 mg
|
Film-Coated Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
05 April 2023
|
05 April 2028
|
| View |
|
DRP-13752
|
Clarithromycin
|
Clartrixel
|
500 mg
|
Film-Coated Tablet
|
-
|
Umedica Laboratories Pvt. Ltd.
|
India
|
Initial
|
05 April 2023
|
05 April 2028
|
| View |
|
DR-XY48691
|
Mometasone furoate (as monohydrate)
|
Momenex
|
50 mcg/actuation
|
aqueous nasal spray
|
-
|
Synmosa Biopharma Corporation (Synmosa Plant)
|
Taiwan
|
Initial
|
05 April 2023
|
05 April 2028
|