| View |
|
DR-XY48097
|
Sevelamer Carbonate
|
Sevela
|
800mg
|
Film Coated Tablet
|
Phosphate Binder
|
Chen Ho Pharmaceutical Co., Ltd. (Sinying Plant)
|
Taiwan
|
Initial
|
08 June 2022
|
08 June 2027
|
| View |
|
DR-XY48096
|
Monobasic Sodium Phosphate + Dibasic Sodium
Phosphate
|
Phospho-Soda
|
24.4 g / 10.8 g per 45 mL
|
Oral Solution
(Ginger Lemon Flavor)
|
Laxative
|
Casen Recordati, S.L.
|
Spain
|
Initial
|
08 June 2022
|
08 June 2027
|
| View |
|
DRP-12139
|
Palonosetron (as hydrochloride)
|
Paloset
|
50 mcg/mL (250 mcg/5mL)
|
Solution for Injection (IV)
|
Antiemetic/Antinauseant [Serotonin (5HT3) antagonist]
|
Aspiro Pharma Limited
|
India
|
Initial
|
20 June 2022
|
20 June 2027
|
| View |
|
DRP-12083
|
Palonosetron (as hydrochloride)
|
Palnos
|
50 mcg/mL (250 mcg 15 mL)
|
Solution for Intravenous
Injection
|
Anti-emetic/ Anti-nauseant
(Serotonin [5HT3] Antagonist)
|
PT. Ferron Par Pharmaceuticals
|
Indonesia
|
Initial
|
10 June 2022
|
10 June 2027
|
| View |
|
DRP-12127
|
Esomeprazole (as Magnesium Trihydrate)
|
Novapraz-20
|
20mg
|
Enteric Coated Tablet
|
Proton Pump Inhibitor
|
ACME Formulation Pvt. Ltd.
|
India
|
Initial
|
16 June 2022
|
16 June 2027
|
| View |
|
DR-XY48109
|
Amlodipine (as besilate)
|
None
|
5 mg
|
Tablet
|
Calcium Channel Blocker
|
The Government Pharmaceutical Organization (Production Plant I-GPO Thanyaburi)
|
Thailand
|
Initial
|
17 June 2022
|
17 June 2027
|
| View |
|
DR-XY48086
|
Amlodipine (as besilate)
|
None
|
10 mg
|
Tablet
|
-
|
The Government Pharmaceutical Organization (Production Plant I-GPO Thanyaburi)
|
Thailand
|
Initial
|
03 June 2022
|
03 June 2027
|
| View |
|
DRP-12074
|
Isoniazid
|
None
|
300 mg
|
Tablet
|
Antituberculosis (Hydrazide)
|
Oxalis Labs
|
India
|
Initial
|
07 June 2022
|
07 June 2027
|
| View |
|
DRP-12075
|
Isoniazid
|
None
|
300 mg
|
Tablet
|
Antituberculosis (Hydrazide)
|
Oxalis Labs
|
India
|
Initial
|
07 June 2022
|
07 June 2027
|
| View |
|
DRP-12068
|
Losartan potassium + Hydrochlorothiazide
|
None
|
50mg/12.5 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB)/Diuretic
|
United International Pharma Co. Ltd.
|
Vietnam
|
Initial
|
07 June 2022
|
07 June 2027
|
| View |
|
DRP-12030
|
Letrozole
|
None
|
2.5 mg
|
Film-Coated Tablet
|
Antineoplastic (Aromatase Inhibitor)
|
Eugia Pharma Specialities Limited
|
India
|
Initial
|
31 May 2022
|
31 May 2027
|
| View |
|
DRP-12087
|
Bisoprolol (as Fumarate)
|
None
|
2.5 mg
|
Film-Coated Tablet
|
Beta-Adrenoceptor Blocker, Selective
|
United International Pharma Co.
|
Vietnam
|
Initial
|
09 June 2022
|
09 June 2027
|
| View |
|
DR-XY48098
|
Bisoprolol fumarate
|
None
|
5 mg
|
Film-Coated Tablet
|
Beta-Adrenoceptor Blocker
|
United International Pharma Co., Ltd.
|
Vietnam
|
Initial
|
09 June 2022
|
09 June 2027
|
| View |
|
DRP-12034
|
Cefixime (as trihydrate)
|
None
|
200 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
Nectar Lifesciences Limited (Unit VI)
|
India
|
Initial
|
01 June 2022
|
01 June 2027
|
| View |
|
DRP-12033
|
Cefixime (as trihydrate)
|
None
|
400 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
Nectar Lifesciences Limited (Unit VI)
|
India
|
Initial
|
01 June 2022
|
01 June 2027
|
| View |
|
DRP-12105
|
Diclofenac (as diethylamine)
|
None
|
10 mg/g (1% w/w)
|
Topical Gel
|
-
|
Rhydburg Pharmaceuticals Ltd.
|
India
|
Initial
|
13 June 2022
|
13 June 2027
|
| View |
|
DRP-12120
|
Imatinib (as mesilate)
|
Imaviate
|
100 mg
|
Capsules
|
Antineoplastic (BCR-ABL tyrosine kinase inhibitor)
|
Adamed Pharma S.A
|
Poland
|
Initial
|
15 June 2022
|
15 June 2027
|
| View |
|
DRP-12121
|
Imatinib (as mesilate)
|
Imavitae
|
400 mg
|
Capsules
|
Antineoplastic (BCR-ABL tyrosine kinase inhibitor)
|
Adamed Pharma S.A
|
Poland
|
Initial
|
15 June 2022
|
15 June 2027
|
| View |
|
DRP-12080
|
Nebivolol (as hydrochloride)
|
Nevolyf-5
|
5 mg
|
Tablet
|
Beta Blocking Agent
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
09 June 2022
|
09 June 2027
|
| View |
|
DRP-12081
|
Nebivolol (as hydrochloride)
|
Nevolf-2.5
|
2.5 mg
|
Tablet
|
Beta Blocking Agent
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
09 June 2022
|
09 June 2027
|