| View |
|
DRP-11753
|
Drospirenone + Ethinylestradiol
|
Drospill
|
3 mg/30 mcg
|
Film-Coated Tablet
|
Hormonal Contraceptive
|
Sun Pharmaceutical Industries Ltd.
|
India
|
Initial (Reconstruction)
|
31 May 2024
|
26 April 2027
|
| View |
|
DRP-11664
|
Cefotaxime (As Sodium)
|
Ausfotaxime
|
1g
|
Powder For Injection (IM/IV)
|
Antibacterial (Third-generation Cephalosporin)
|
Union Korea Pharm Co., Ltd.
|
Korea
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
|
DR-XY47969
|
Triamcinolone Acetonide
|
Tricort
|
1 mg/mL (0.1% w/v)
|
Scalp Lotion
|
Topical Corticosteroid
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
27 April 2022
|
27 April 2027
|
| View |
|
DRP-11663
|
Cefotaxime (As Sodium)
|
Retax
|
1g
|
Powder For Injection (IM/IV)
|
Antibacterial (Third-generation Cephalosporin)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
|
DR-XY47982
|
Quetiapine (as fumarate)
|
Q-Mind ER 50
|
50 mg
|
Extended-Release Tablet
|
Antipsychotic
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
28 April 2022
|
28 April 2027
|
| View |
|
DRP-11412
|
Cefepime (as hydrochloride)
|
Seabact-2000
|
2g
|
Powder for Injection (IV)
|
-
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
|
DRP-11413
|
Cefepime Hydrochloride
|
Seabact-1000
|
1 g
|
Powder for Injection (IV)
|
Antibacterial (Fourth-generation Cephalosporin)
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
|
DRP-11725
|
Salbutamol (As Sulfate)
|
None
|
2 mg
|
Tablet
|
Selective beta-2-adrenoreceptor agonists
|
Phil. United Pharma Corporation
|
Philippines
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
|
DR-XY47980
|
Norepinephrine (as bitartrate)
|
None
|
1 mg/mL (4 mg/4 mL)
|
Concentrate Solution for IV Infusion
|
Adrenergic and dopaminergic agent
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
28 April 2022
|
28 April 2027
|
| View |
DR-XY47959_PI_01.pdf
|
DR-XY47959
|
Sevelamer Carbonate
|
Nephvela
|
800mg
|
Film Coated Tablet
|
Phosphate Binder
|
Synthon Hispania SL
|
Spain
|
Monitored Release
|
22 April 2022
|
22 April 2027
|
| View |
|
DR-XY47973
|
Hypromellose
|
Misty
|
3 mg/mL
|
Ophthalmic Solution
|
Surgical Aids (Viscoelastic substances)
|
Millimed BFS Co., Ltd.
|
Thailand
|
Initial
|
28 April 2022
|
28 April 2027
|
| View |
|
DRP-11727
|
Ampicillin (As Sodium) + Sulbactam(As Sodium)
|
Lintam
|
1 g/500 mg
|
Powder For Solution For Injection (I.M/I.V.)
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Inject Care Parenterals Pvt. Ltd.
|
India
|
Initial
|
22 April 2022
|
22 April 2027
|
| View |
|
DRP-11773
|
Clarithromycin
|
Kracid
|
500mg
|
Film-Coated Tablet
|
Antibacterial (Macrolide)
|
Fredun Pharmaceuticals Ltd.
|
India
|
Initial
|
27 April 2022
|
27 April 2027
|
| View |
|
DR-XY47972
|
Gemcitabine
|
Gemibine-2000
|
2g
|
Lyophilized Powder for Injection (IV)
|
-
|
Intas Pharmaceuticals Limited
|
India
|
-
|
28 April 2022
|
28 April 2027
|
| View |
|
DRP-11676
|
Gemcitabine (As Hydrochloride)
|
Gemaccord 2000
|
100mg/mL (2g/20mL)
|
Concentrate for Solution for IV Infusion
|
Antineoplastic (Pyrimidine analogue)
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
13 April 2022
|
13 April 2027
|
| View |
|
DRP-11673
|
Gemcitabine (As Hydrochloride)
|
Gemaccord 200
|
1000mg/mL (200mg/2mL)
|
Concentrate for Solution for IV Infusion
|
-
|
Intas Pharmaceuticals Limited
|
India
|
-
|
13 April 2022
|
13 April 2027
|
| View |
|
DRP-11675
|
Gemcitabine (As Hydrochloride)
|
Gemaccord 1500
|
100mg/mL (1.5g/15mL)
|
Concentrate for Solution for IV Infusion
|
Antineoplastic (Pyrimidine analogues)
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
13 April 2022
|
13 April 2027
|
| View |
|
DRP-11674
|
Gemcitabine (As Hydrochloride)
|
Gemaccord 1000
|
1000mg/10mL (1g/10mL)
|
Concentrate for Solution for IV Infusion
|
-
|
Intas Pharmaceuticals Limited
|
India
|
-
|
13 April 2022
|
13 April 2027
|
| View |
|
DR-XY47971 (For Export Use Only)
|
Thiamine mononitrate (Vitamin B1) + Pyridoxine
hydrochloride (Vitamin B6) + Folic Acid (Vitamin B9) +
Cyanocobalamin (Vitamin B12) + Iron
|
Fortifer-FA
|
Each film-coated tablet contains:
Iron, elemental (as Ferrous Fumarate 300 mg) 98.6 mg; Folic Acid 500 mcg; Thiamine Mononitrate (Vitamin B1) 5 mg; Pyridoxine Hydrochloride (Vitamin B6) 5 mg; Cyanocobalamin (Vitamin B12) 15 mcg
|
Film-Coated Tablet
|
Anti-Anemia/Hematinic
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial
|
28 April 2022
|
28 April 2027
|
| View |
|
DRP-11779
|
Iron
|
Ferrocap
|
150mg
|
Capsule
|
Mineral (Hematinic/Anti-anemia)
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Automatic Renewal (E-AR)
|
31 December 2023
|
28 April 2029
|