| View |
DR-XY48834_PI_01.pdf
|
DR-XY48834
|
Cabotegravir
|
Apretude
|
200 mg/mL (600 mg/3 mL)
|
Prolonged-Release
Suspension for Intramuscular Injection (Gluteal)
|
-
|
Glaxo Operations UK Limited
|
United Kingdom
|
Monitored Release
|
03 August 2023
|
03 August 2028
|
| View |
DR-XY48835_PI_01.pdf
|
DR-XY48835
|
Cabotegravir (as sodium)
|
Apretude
|
30mg
|
Film-Coated Tablet
|
-
|
Glaxo Operations UK Limited (trading as Glaxo
Wellcome Operations
|
United Kingdom
|
Monitored Release
|
03 August 2023
|
03 August 2028
|
| View |
|
DRP-8845-01
|
Mometasone Furoate
|
Momeclir
|
500 mcg/mL
|
Nasal Spray Suspension
|
-
|
Hanlim Pharmaceutical Co., Ltd
|
Korea
|
CLIDP Conversion
|
11 April 2023
|
01 December 2025
|
| View |
|
DRP-5834-04
|
Ceftriaxone (as sodium)
|
Onafix
|
1 g
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Cephalosporin)
|
Kyung Dong Pharm Co., Ltd
|
Korea
|
Renewal
|
07 August 2023
|
12 September 2028
|
| View |
|
DRP-14264
|
Levetiracetam
|
Zeiskon
|
500 mg
|
Film-Coated Tablet
|
-
|
CONSERN PHARMA LIMITED
|
India
|
Initial
|
04 August 2023
|
04 August 2028
|
| View |
|
DR-XY48828
|
Linezolid
|
Zoldap
|
600mg
|
Film-Coated Tablet
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
02 August 2023
|
02 August 2028
|
| View |
|
DRP-14235
|
Adapalene
|
None
|
3 mg/g (0.3% w/w)
|
Topical Gel
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial
|
01 August 2023
|
01 August 2028
|
| View |
|
DRHR-2273
|
Ethyl Alcohol
|
Alcoshield
|
70 mL per 100 mL (70% v/v)
|
Solution
|
-
|
Nue Ark Philippines Inc.
|
Philippines
|
Initial
|
04 August 2023
|
04 August 2028
|
| View |
|
DRHR-2269
|
Isopropyl Alcohol
|
None
|
70 mL per 100 mL (70% v/v)
|
Topical Solution
|
-
|
Nue Ark Philippines Inc.
|
Philippines
|
Initial
|
31 July 2023
|
31 July 2028
|
| View |
|
DRP-14263
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Surpitam-1.5
|
1 g/500
|
Powder for Injection (I.M./I.V.)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial (Re-application)
|
04 August 2023
|
04 August 2028
|
| View |
|
DRP-14262
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Surpitam-750
|
500mg/250mg
|
Powder for Injection (I.M./I.V.)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial (Re-application)
|
04 August 2023
|
04 August 2028
|
| View |
|
DRP-14229
|
Calcium Carbonate
|
Rapcenate
|
500 mg
|
Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial [OTC]
|
31 July 2023
|
31 July 2028
|
| View |
|
DRP-14230
|
Calcium Carbonate
|
Rapcenate
|
1.25g (Equivalent to 500mg Elemental Calcium)
|
Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial [OTC]
|
01 August 2023
|
01 August 2028
|
| View |
|
DRP-14231
|
Calcium + Cholecalciferol
|
Rapcenate Plus D
|
600 mg/ 400 IU
|
Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial [OTC]
|
01 August 2023
|
01 August 2028
|
| View |
|
DRP-14227
|
Guaifenesin + Phenylpropanolamine Hydrochloride +
Chlorphenamine Maleate
|
Mucunxt
|
100 mg/ 6.5 mg/ 2 mg per 5mL
|
Syrup
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial [OTC]
|
31 July 2023
|
31 July 2028
|
| View |
|
DRP-14218
|
Ceftazidime (As Sodium)
|
Medtazime
|
1 g
|
Powder For Injection (Im/Iv)
|
-
|
Ananta Medicare Limited
|
India
|
Initial
|
28 July 2023
|
28 July 2028
|
| View |
|
DRP-14228
|
Cetirizine Dihydrochloride
Hydrochloride
|
Allecur Plus
|
5mg/10mg
|
Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial [OTC]
|
31 July 2023
|
31 July 2028
|
| View |
|
DRP-14241
|
Levetiracetam
|
Levetrex
|
250mg
|
Film Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
02 August 2023
|
02 August 2028
|
| View |
|
DRP-14242
|
Levetiracetam
|
Levetrex
|
500mg
|
Film Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
02 August 2023
|
02 August 2028
|
| View |
|
DRP-14170
|
Enzalutamide
|
Myeloc
|
40mg
|
Capsule
|
-
|
Globela Pharma Private Limited.
|
India
|
Initial
|
01 August 2023
|
01 August 2028
|