| View |
DR-XY48372_PI_01.pdf
|
DR-XY48372
|
Nilotinib (as hydrochloride dihydrate)
|
Nicmel 150
|
150mg
|
Capsules
|
Antineoplastic agent (BCR-ABL tyrosine kinase inhibitor)
|
Hetero Labs Limited (Unit V and Unit V-A)
|
India
|
Monitored Release (Re-application)
|
11 October 2022
|
11 October 2027
|
| View |
|
DRP-12825
|
Sodium Bicarbonate
|
None
|
84 mg/mL (8.4% w/v)
|
Solution for Intravenous (IV) Injection
|
Electrolyte Solution
|
Aculife Healthcare Private Limited
|
India
|
Initial
|
11 October 2022
|
11 October 2027
|
| View |
DRP-12818_PI_01.pdf
|
DRP-12818
|
Silver Sulfadiazine
|
Argyrex
|
10 mg/g (1% w/w)
|
Topical Cream
|
Antibacterial (Sulfonamide)
|
Lincoln Pharmaceuticals Ltd.
|
India
|
Initial
|
10 October 2022
|
10 October 2027
|
| View |
DR-XY48411_PI_01.pdf
|
DR-XY48411
|
Trifluridine + Tipiracil (as Hydrochloride)
|
Lonsurf
|
15 mg/6.14 mg
|
Film-Coated Tablet
|
-
|
Taiho Pharmaceutical Co., Ltd. (Kitajima Plant)
|
Japan
|
Monitored Release (Reconstruction)
|
19 October 2023
|
07 October 2027
|
| View |
DR-XY48410_PI_01.pdf
|
DR-XY48410
|
Trifluridine + Tipiracil (as Hydrochloride)
|
Lonsurf
|
20 mg/8.19 mg
|
Film-Coated Tablet
|
Antineoplastic Agents
|
Taiho Pharmaceutical Co., Ltd. (Kitajima Plant)
|
Japan
|
Monitored Release (Reconstruction)
|
19 October 2023
|
07 October 2027
|
| View |
|
DRP-12829
|
Calcium Sennosides
|
Slimgen
|
8.77 mg
|
Tablet
|
Stimulant Laxative
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (OTC)
|
13 October 2022
|
13 October 2027
|
| View |
|
DRP-12804
|
Verapamil Hydrochloride
|
Saphvera
|
80 mg
|
Film Coated Tablet
|
Calcium Channel Blocker (Phenylalkylamine Derivative)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12805
|
Verapamil Hydrochloride
|
Saphvera
|
40 mg
|
Film Coated Tablet
|
Calcium Channel Blocker (Phenylalkylamine Derivative)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12550
|
Sodium Chloride.
|
none
|
9 mg/mL (0.9% w/v)
|
Solution for I.V. Infusion
|
Electrolyte Replenisher
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
18 June 2024
|
07 October 2027
|
| View |
|
DRP-12787
|
Potassium Chloride
|
None
|
2 mEq/mL
|
Solution for Injection (IV Infusion)
|
Electrolyte
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
06 March 2023
|
07 October 2027
|
| View |
|
DRP-12859
|
Tenofovir Alafenamide (as fumarate)
|
Taflon
|
25mg
|
Tablet
|
Nucleoside and Nucleotide Reverse Transcriptase Inhibitor
|
Shijiazhuang Lonzeal Pharmaceuticals Co., Ltd.
|
China
|
Initial
|
17 October 2022
|
17 October 2027
|
| View |
DRP-12812_PI_01.pdf
|
DRP-12812
|
Sertaconazole (As Nitrate)
|
Sertatop
|
20 mg/g (2% w/w)
|
Topical Cream
|
Antifungal (Imidazole and Triazole Derivative)
|
Yash Pharmaceuticals
|
India
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
DR-XY48422
|
Ticagrelor
|
Cleverge
|
90 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Platelet Aggregation Inhibitor excl. heparin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
13 October 2022
|
13 October 2027
|
| View |
|
DR-XY48415
|
Sterile Water for Injection
|
None
|
10 mL
|
Sterile Water for Injectio
|
Parenteral Diluent
|
CSPC Ouyi Pharmaceutical Co. Ltd.
|
China
|
Initial
|
12 October 2022
|
12 October 2027
|
| View |
|
DRP-12788
|
Omeprazole
|
Omeprasaph
|
40 mg
|
Delayed-Release Capsule
|
Proton Pump Inhibitor
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12844
|
Ticagrelor
|
None
|
90 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Platelet Aggregation Inhibitor excl. heparin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
13 October 2022
|
13 October 2027
|
| View |
|
DRP-12819
|
Tigecycline
|
Tylin
|
50 mg
|
Lyophilized Powder for Injection for Intravenous (IV) Infusion
|
Antibacterial (Tetracycline) :
|
Gufic Biosciences Limited
|
India
|
Initial
|
10 October 2022
|
10 October 2027
|
| View |
|
DR-XY48417
|
Calcium Carbonate + Colecalciferol (Vitamin D3)
|
None
|
500 mg/ 200 IU
|
Film-Coated Tablet
|
-
|
Factors Group of Nutritional Companies Inc
|
Canada
|
Initial (OTC)
|
13 October 2022
|
13 October 2027
|
| View |
|
DRP-12784
|
Salbutamol (As Sulfate)
|
Lumeneurol
|
1 mg/mL (2.5 mg/ 2.5 mL)
|
Solution For Inhalation
|
Bronchodilator
|
Ha Noi CPC1 Pharmaceutical Joint Stock Company
|
Vietnam
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12785
|
Salbutamol (As Salbutamol Sulfate) + Ipratropium Bromide
|
Bronchosal
|
1 mg/200 mcg per mL
|
Solution for Inhalation
|
-
|
Ha Noi CPC1 Pharmaceutical Joint Stock Company
|
Vietnam
|
Initial
|
07 October 2022
|
07 October 2027
|