| View |
|
HRP-543
|
Tretinoin
|
Beautamin-A 0.025%
|
250 mcg/g (0.025% w/w)
|
Topical Cream
|
Anti-Acne
|
Carmel Laboratories, Inc.
|
Philippines
|
Initial [Household Remedy) (Correction)
|
28 October 2022
|
14 September 2027
|
| View |
|
DRP-12597
|
Nicardipine Hydrochloride
|
Nicarduz
|
1 mg/mL (10 mg/10 mL)
|
Solution For Injection (IV Infusion)
|
-
|
Scott-Edil Pharmacia Limited
|
India
|
Initial
|
12 September 2022
|
12 September 2027
|
| View |
|
HRP-547
|
Tretinoin
|
Beutamin-A 0.05%
|
500mcg per g (0.05% w/w)
|
Topical Cream
|
Anti-Acne
|
Carmel Laboratories, Inc.
|
Philippines
|
Initial [HR][PCPR)
|
23 September 2022
|
23 September 2027
|
| View |
|
DRP-12583
|
Omeprazole (As Sodium)
|
Giozole
|
40mg
|
Lyophilized Powder for Injection (IV Infusion)
|
Proton Pump Inhibitor
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
08 September 2022
|
08 September 2027
|
| View |
|
DRP-12596
|
Oxaliplatin
|
Novaplatin
|
100 mg
|
Lyophilized Powder for Injection (IV Infusion)
|
Antineoplastic Agent (Platinum compound)
|
Chong Kun Dang Pharmaceutical Corp.
|
Korea
|
Initial
|
12 September 2022
|
12 September 2027
|
| View |
|
DRP-12598
|
Palonosetron (As Hydrochloride)
|
Lonset IV
|
50 mcg/mL (250 mcg/5 mL)
|
Solution for Injection (IV)
|
-
|
Sichuan Huiyu Pharmaceutical Company Limited
|
China
|
Initial (Reconstruction)
|
18 January 2024
|
12 September 2027
|
| View |
|
DRP-12614
|
Ferrous Sulfate
|
Ironfer
|
325 mg Tablet (equivalent to 105 mg elemental Iron)
|
Tablet
|
Anti-Anemia
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
15 September 2022
|
15 September 2027
|
| View |
|
DRP-12616
|
Ferrous Sulfate
|
Ferrogen
|
325 mg Tablet (equivalent to 105 mg elemental Iron)
|
Tablet
|
Antianemic
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
15 September 2022
|
15 September 2027
|
| View |
|
DRP-12605
|
Temozolomide
|
Tamina
|
20mg
|
Capsule
|
-
|
Globela Pharma Private Limited
|
india
|
Initial
|
13 September 2022
|
13 September 2027
|
| View |
|
DRP-12603
|
Temozolomide
|
Tamina
|
250mg
|
Capsule
|
-
|
Globela Pharma Private Limited
|
india
|
Initial
|
13 September 2022
|
13 September 2027
|
| View |
|
DRP-12604
|
Temozolomide
|
Tamina
|
100mg
|
Capsule
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
13 September 2022
|
13 September 2027
|
| View |
|
DRP-12615
|
Ferrous Sulfate
|
Ironfer
|
325 mg (eq. to 104.84 mg elemental Iron)
|
Tablet
|
Antianemic
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
15 September 2022
|
15 September 2027
|
| View |
|
DRP-12617
|
Ferrous Sulfate
|
Ferrogen
|
325 mg (eq. to 105 mg elemental Iron)
|
Tablet
|
Antianemic
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (OTC)
|
15 September 2022
|
15 September 2027
|
| View |
|
DRP-12613
|
Ferrous Sulfate
|
Feruz
|
325 mg (eq. to 105 mg elemental Iron)
|
Tablet
|
Antianemic
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (OTC)
|
15 September 2022
|
15 September 2027
|
| View |
|
DRP-12551
|
Sodium Bicarbonate
|
None
|
84 mg/mL (8.4% w/v)
|
Solution for Injection (I.V.)
|
Electrolyte Replenisher/ Systemic Alkalinising Agent
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
09 September 2022
|
09 September 2027
|
| View |
|
DRHR-2151
|
Ethyl Alcohol
|
Hygienix
|
70 % v/v
|
Solution
|
Antiseptic/ Disinfectant
|
Splash Corporation
|
Philippines
|
Initial
|
15 September 2022
|
15 September 2027
|
| View |
|
DR-XY48348
|
Flupentixol Decanoate
|
Flupenxol
|
20mg/mL
|
Solution for Injection (IM)
|
Antipsychotic (Thioxanthene derivative)
|
Ciron Drugs & Pharmaceuticals Pvt. Limited
|
india
|
Initial
|
13 September 2022
|
13 September 2027
|
| View |
DR-XY48357_PI_01.pdf
|
DR-XY48357
|
Solifenacin Succinate
|
Solifen
|
10mg
|
Film-Coated Tablet
|
Urological (Drugs for urinary frequency and
incontinence)
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
15 September 2022
|
15 September 2027
|
| View |
DR-XY48356_PI_01.pdf
|
DR-XY48356
|
Solifenacin Succinate
|
Solifen
|
5mg
|
Film-Coated Tablet
|
Urological (Drugs for urinary frequency and incontinence)
|
Getz Pharma (Pvt.) Ltd.
|
Pakistan
|
Initial
|
15 September 2022
|
15 September 2027
|
| View |
|
DRP-12573
|
Calcium Lactate
|
None
|
650 mg
|
Tablet
|
Mineral
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (OTC)
|
06 September 2022
|
06 September 2027
|