| View |
|
DRHR-2358
|
Hydroquinone + Tretinoin
|
None
|
18 mg/100 mcg per mL (1.8% /0.01% w/v)
|
Topical Solution
|
Depigmenting Agent/Anti-acne.
|
Altum International Cosmeceutical Manufacturing
Inc.
|
Philippines
|
Initial
|
10 May 2024
|
10 May 2029
|
| View |
|
DRHR-2356
|
Tretinoin
|
None
|
100 mcg per mL (0.01% w/v)
|
Topical Solution
|
Anti-acne
|
Altum International Cosmeceutical Manufacturing
Inc.
|
Philippines
|
Initial
|
10 May 2024
|
10 May 2029
|
| View |
|
DR-XY49076
|
Febuxostat
|
Euricstat
|
40 mg
|
Film-Coated Tablet
|
Antigout
|
The Acme Laboratories Limited
|
Bangladesh
|
Initial
|
10 May 2024
|
10 May 2029
|
| View |
|
DRP-15137
|
Remifentanil (as hydrochloride)
|
Fentare
|
2mg
|
Lyophilized Powder for Injection (I.V.)
|
Opioid Anesthetic
|
Yichang Humanwell Pharmaceutical Co., Ltd.
|
China
|
Initial
|
10 May 2024
|
10 May 2029
|
| View |
|
DRP-15138
|
Remifentanil (as hydrochloride)
|
Fentare
|
1 mg
|
Lyophilized Powder for Injection (I.V.)
|
Opioid Anesthetic
|
Yichang Humanwell Pharmaceutical Co., Ltd.
|
China
|
Initial
|
10 May 2024
|
10 May 2029
|
| View |
|
DRP-15142
|
0.9% Sodium Chloride
|
None
|
900 mg/100 mL (0.9% w/v)
|
Solution for IV Infusion
|
Electrolyte Solution
|
Aculife Healthcare Private Limited
|
India
|
Initial
|
13 May 2024
|
13 May 2029
|
| View |
|
DR-XY49077
|
Dienogest
|
Evafact
|
2 mg
|
Tablet
|
Progestogen (Pregnadien derivative)
|
Naari Pharma Private Limited
|
India
|
Initial
|
13 May 2024
|
13 May 2029
|
| View |
|
DR-XY49079
|
Bosentan (as monohydrate)
|
Bosenpah 125
|
125 mg
|
Film-Coated Tablet
|
Antihypertensive for Pulmonary Arterial Hypertension
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
14 May 2024
|
14 May 2029
|
| View |
|
DRP-15150
|
Trimetazidine Hydrochloride
|
Trimecard MR 35
|
35 mg
|
Film-Coated Tablet
|
Other Cardiac Preparation
|
PSA Chemicals & Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
14 May 2024
|
14 May 2029
|
| View |
|
DRP-15143
|
Ceftriaxone (as sodium)
|
Stopirax
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Third-generation cephalosporin)
|
M&H Manufacturing Co., Ltd.
|
Thailand
|
Initial
|
13 May 2024
|
13 May 2029
|
| View |
DR-XY36724_PI_01.pdf
|
DR-XY36724
|
Levofloxacin (as hemihydrate)
|
Quiflox
|
750 mg
|
Film-Coated Tablet
|
Antibacterial (Fluoroquinolones)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Renewal
|
06 July 2024
|
29 September 2029
|
| View |
|
DR-XY49071
|
Irbesartan
|
Bezartan
|
150 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Duopharma Manufacturing (Bangi) Sdn. Bhd.
|
Malaysia
|
Initial (Re-application)
|
06 May 2024
|
06 May 2029
|
| View |
|
DRP-11930-02
|
Metformin hydrochloride
|
None
|
500 mg
|
Film-Coated Tablets
|
Blood Glucose Lowering Drugs (Biguanide)
|
Fredun Pharmaceuticals Limited
|
India
|
CLIDP Conversion
|
15 May 2024
|
20 May 2027
|
| View |
|
DRP-12091-01
|
Paracetamol
|
Molpraxx
|
10 mg/mL (1g/100 mL)
|
Solution for I.V. Infusion
|
Analgesic/Antipyretic
|
Centurion ?laç Sanayi ve Ticaret A.?. Ankara Subesi
|
Turkey
|
CLIDP Conversion
|
12 May 2024
|
10 June 2027
|
| View |
|
DRP-12091-02
|
Paracetamol
|
Newpamol
|
10 mg/mL (1g/100 mL)
|
Solution for I.V. Infusion
|
Analgesic/Antipyretic
|
Centurion ?laç Sanayi ve Ticaret A.?. Ankara Subesi
|
Turkey
|
CLIDP Conversion
|
12 May 2024
|
10 June 2027
|
| View |
|
DRP-12129-03
|
Meropenem (as trihydrate)
|
Arunem
|
500 mg
|
Powder for Injection (I.V.)
|
Antibacterial (Carbapenem)
|
Mepromax Lifesciences Pvt. Ltd.
|
India
|
CLIDP Conversion
|
12 May 2024
|
15 December 2029
|
| View |
|
DRP-12412-09
|
Losartan Potassium
|
Zartapel
|
50 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Antagonist
|
Azarias Pharmaceutical Laboratories Inc
|
Philippines
|
CLIDP Conversion
|
12 May 2024
|
03 August 2025
|
| View |
|
DRP-12544-04
|
Azithromycin (as dihydrate)
|
Retazith
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Macrolide)
|
AMN Life Pvt. Ltd
|
India
|
CLIDP Conversion
|
12 May 2024
|
31 August 2027
|
| View |
|
DRP-12600-07
|
Febuxostat
|
None
|
80 mg
|
Film-Coated Tablet
|
Antigout
|
Sunrise International Labs Limited
|
India
|
CLIDP Conversion
|
14 May 2024
|
14 September 2027
|
| View |
|
DRP-12600-08
|
Febuxostat
|
None
|
80 mg
|
Film-Coated Tablet
|
Antigout
|
Sunrise International Labs Limited
|
India
|
CLIDP Conversion
|
14 May 2024
|
14 September 2027
|