| View |
|
DRP-13065
|
Phenytoin Sodium
|
Saphenytoin
|
50 mg/mL
|
Solution For Injection (I.M./I.V.)
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial (Variation)
|
09 August 2023
|
09 August 2028
|
| View |
|
DRP-13110
|
Methotrexate
|
Trexasaph-25
|
25 mg/mL
|
Solution For Injection (IM/IV)
|
-
|
Health Biotech Ltd.
|
India
|
Initial
|
02 December 2022
|
02 December 2027
|
| View |
|
DRP-13111
|
Ceftriaxone (As Sodium)
|
Ceftisaph-1000
|
1g
|
Powder For Injection (IM/IV)
|
-
|
Bueno Salud Care (India) Pvt. Ltd.
|
China
|
Initial
|
02 December 2022
|
02 December 2027
|
| View |
|
DRP-13130
|
Levocetirizine Dihydrochloride
|
Cetalore
|
5mg
|
Film-Coated Tablet
|
-
|
KLM Laboratories Pvt. Ltd.
|
India
|
Initial
|
05 December 2022
|
05 December 2027
|
| View |
|
DRP-13102
|
Celecoxib
|
Sanxib
|
200 mg
|
Capsule
|
-
|
Gracure Pharmaceutical Ltd.
|
India
|
Initial
|
01 December 2022
|
01 December 2027
|
| View |
DR-XY48485_PI_01.pdf
|
DR-XY48485
|
Peritoneal Dialysis Solution With 2.3% Dextrose
|
Peritoneal Dialysis Solution with 2.3 % Dextrose
|
Formulation:
Each L of Solution contains:
Glucose (Dextrose) 22.73 g
equivalent to 25.0 g glucose monohydrate
Sodium Chloride
5.786 g
Sodium Lactate
3.925 g
Calcium Chloride Dihydrate
257.3 mg
Magnesium Chloride Hexahydrate
101.7 mg
|
Solution for Peritoneal Dialysis
|
Peritoneal Dialytic
|
Fresenius Medical Care Production Sdn. Bhd.
|
Malaysia
|
Initial (Variation)
|
31 July 2024
|
31 July 2029
|
| View |
|
DRP-13124
|
Cefuroxime (as Axetil)
|
Zefucare
|
500mg
|
Film coated tablet
|
-
|
Sance Laboratories Pvt. Ltd.
|
India
|
Initial
|
05 December 2022
|
05 December 2027
|
| View |
|
DRP-13106
|
Telmisartan
|
Telminorm-80
|
80 mg
|
Tablet
|
Angeotensin Ii Receptor Antagonist
|
Ipca Laboratories Ltd.
|
India
|
Initial
|
01 December 2022
|
01 December 2027
|
| View |
|
DRP-13107
|
Erlotinib (as hydrochloride)
|
Erlocip 100
|
100 mg
|
Film-Coated Tablet
|
-
|
Cipla Limited (Unit X)
|
India
|
Initial
|
01 December 2022
|
01 December 2027
|
| View |
|
DRP-13121
|
Levocetirizine (as Hydrochloride)
|
Allerzine
|
500mcg/mL
|
Syrup
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial
|
02 December 2022
|
02 December 2027
|
| View |
|
DRP-13115
|
Co - Amoxiclav
|
Meoxiclav-DS 312.5
|
312.5 mg per 5 mL
|
Powder For Oral Suspension
|
-
|
Giyaan Pharma Private Limited
|
India
|
Initial
|
02 December 2022
|
02 December 2027
|
| View |
|
DRP-13118
|
Epirubicin Hydrochloride
|
None
|
10 mg
|
Lyophilized Powder For Injection (IV)
|
-
|
Venus Remedies, Limited
|
India
|
Initial (Correction)
|
23 January 2023
|
02 December 2027
|
| View |
|
DRP-13119
|
Gemcitabine (As Hydrochloride)
|
None
|
1 g
|
Lyophilized Powder for Injection (IV Infusion)
|
-
|
Venus Remedies, Limited
|
India
|
Initial (Correction)
|
23 January 2023
|
02 December 2027
|
| View |
|
DRP-13120
|
Tadalafil
|
None
|
20 mg
|
Film-Coated Tablet
|
-
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial
|
02 December 2022
|
02 December 2027
|
| View |
|
DRP-13097
|
Magnesium Trisilicate + Aluminum Hydrozide +
Simethicone
|
Antamac
|
500mg/ 250 mg/ 25 mg per 5 mL
|
Oral Suspension
|
-
|
KCK Pharmaceutical Industries Sdn. Bhd.
|
Malaysia
|
Initial
|
01 December 2022
|
01 December 2027
|
| View |
|
DR-XY48510
|
Calcium Carbonate
|
Calci-Aid
|
1,250 mg (equivalent to 500 mg Calcium)
|
Softgel Capsule
|
-
|
Catalent Germany Eberbach GmbH
|
Germany
|
Initial
|
01 December 2022
|
01 December 2027
|
| View |
|
DRP-13096
|
Ketoanalogues + Essential Amino Acids
|
Ketomirin
|
630 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
01 December 2022
|
01 December 2027
|
| View |
|
DRHR-2171
|
Eucalyptus Oil + Camphor
|
Zam-buk
|
5.020g/1.760g
|
Ointment
|
-
|
Interthai Pharmaceutical Manufacturing Ltd.
|
Thailand
|
Initial (HR)
|
01 December 2022
|
01 December 2027
|
| View |
|
DRP-13108
|
Rifampicin + Isoniazid + Ethambutol Hydrochloride
|
Triosaph
|
150 mg/75 mg/ 300 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
Malaysia
|
Initial
|
01 December 2022
|
01 December 2027
|
| View |
|
DRP-13117
|
Sitagliptin (as phosphate)
|
Sitaglipsaph-50
|
50 mg
|
Film Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
02 December 2022
|
02 December 2027
|