| View |
|
DRP-12766
|
Paclitaxel
|
Unipacli-30
|
6 mg/mL (30 mg/5 mL)
|
Solution for IV Infusion
|
-
|
Admac Lifesciences
|
India
|
Initial
|
06 October 2022
|
06 October 2027
|
| View |
|
DRP-12767
|
Ivabradine (as hydrochloride)
|
None
|
5 mg
|
Film-Coated Tablet
|
Cardiac Preparation
|
Bafna Pharmaceuticals Limited
|
India
|
Initial
|
05 October 2022
|
05 October 2027
|
| View |
|
DRP-12778
|
Mirtazapine
|
Aurozapine OD 45
|
45 mg
|
Orodispersible Tablet
|
-
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
06 October 2022
|
06 October 2027
|
| View |
|
DRP-12780
|
Mirtazapine
|
None
|
45 mg
|
Orodispersible Tablet
|
-
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
06 October 2022
|
06 October 2027
|
| View |
|
DRP-12779
|
Mirtazapine
|
Aurozapine OD 15
|
15 mg
|
Orodispersible Tablet
|
-
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
06 October 2022
|
06 October 2027
|
| View |
|
DRP-12781
|
Mirtazapine
|
None
|
15 mg
|
Orodispersible Tablet
|
Antidepressant
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
06 October 2022
|
06 October 2027
|
| View |
|
DRP-12739
|
Atracurium Besilate
|
Atracursaph
|
10mg/mL
|
Solution for Injection (IV)
|
Peripherally Acting Muscle Relaxant
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
29 September 2022
|
29 September 2027
|
| View |
|
DRP-12746
|
Azithromycin (as Dihydrate)
|
Hithro
|
500 mg
|
Lyophilized Powder For Injection ( I.V. Infusion)
|
Antibacterial (Macrolide)
|
United Biotech Pvt. Ltd.
|
India
|
Initial
|
05 October 2022
|
05 October 2027
|
| View |
|
DR-XY48389
|
Levofloxacin (as hemihydrate) + Dexamethasone (as
sodium phosphate)
|
Ducressa
|
5 mg / 1 mg per mL
|
Ophthalmic Solution (Eye Drops)
|
Anti-infective-Anti-inflammatory Combination
|
Tubilux Pharma S.p.A.
|
Italy
|
Monitored Release
|
03 October 2022
|
03 October 2027
|
| View |
|
DR-XY48398
|
Tranexamic Acid
|
Actranex
|
500 mg/5 mL (100 mg/mL)
|
Solution for Injection
|
Anti-fibrinolytic
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
04 October 2022
|
04 October 2027
|
| View |
|
DRP-12713
|
Lysozyme + Cetylpyridinium Chloride + Lidocaine Hydrochloride
|
Lysobact Complete Spray
|
20 mg/1.5 mg/0.5 mg per mL
|
Oromucosal Spray Solution
(Peppermint Flavor)
|
Anti-inflammatory/Antiseptic/Local Anesthetic
|
Bosnalijek D.D.
|
Bosnia and Herzegovina
|
Initial (OTC](Correction)
|
28 October 2022
|
03 October 2027
|
| View |
|
DR-XY48406
|
Lurasidone Hydrochloride
|
Lurasitor 80
|
80 mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
06 October 2022
|
06 October 2025
|
| View |
|
DR-XY48390
|
Lurasidone Hydrochloride
|
Lurasitor 40
|
40 mg
|
Film-Coated Tablet
|
Antipsychotic (Indole Derivative)
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
03 October 2022
|
03 October 2025
|
| View |
DR-XY48387_PI_01.pdf
|
DR-XY48387
|
Revefenacin
|
Yupelri
|
175mcg/3mL
|
Solution for Inhalation
|
Anticholinergic
|
The Ritedose Corporation
|
United States of America
|
Monitored Release
|
03 October 2022
|
03 October 2027
|
| View |
|
DRP-12758
|
Brinzolamide
|
Optabrin
|
10 mg/mL (1% w/v)
|
Ophthalmic Suspension
|
Antiglaucoma preparation and Miotic (Carbonic Anhydrase Inhibitor)
|
World Medicine İlaç Sanayi ve Ticaret A.Ş.
|
Turkey
|
Initial
|
03 October 2022
|
03 October 2027
|
| View |
DR-XY48388_PI_01.pdf
|
DR-XY48388
|
Gemigliptin (as tartrate sesquihydrate) + Metformin
hydrochloride
|
Zemimet SR
|
50mg/1 g
|
Film-Coated Tablet
|
Oral Blood Glucose Lowering Drug Combination
|
LG Chem, Ltd.
|
Korea
|
Monitored Release
|
04 October 2022
|
04 October 2025
|
| View |
|
DRP-12743
|
Rivaroxaban
|
None
|
10 mg
|
Film-Coated Tablet
|
Antithrombotic Agent
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
30 September 2022
|
30 September 2027
|
| View |
|
BR-1422
|
Inactivated Poliomyelitis Vaccine (Types 1, 2, and 3)
|
Poliovac
|
Formulation: Each dose (0.5 mL) contains: Inactivated poliovirus type 1, Mahoney strain*40 D antigen units Inactivated poliovirus type 2, MEF-1 strain* 8 D antigen units Inactivated poliovirus type 3, Saukett strain* 32 D antigen units *Cultivated on Vero cells
|
Suspension for Injection (IM/SC)
|
Vaccines
|
Serum Institute of India Private Limited
|
India
|
Initial
|
06 October 2022
|
06 October 2027
|
| View |
|
DR-XY48393
|
Oxycodone Hydrochloride
|
Oxynorm
|
50mg/mL
|
Solution For Injection Or Infusion (SC/IV)
|
Opioid Analgesic
|
Rafa Laboratories Ltd.
|
Israel
|
Monitored Release
|
04 October 2022
|
04 October 2027
|
| View |
|
DR-XY44460
|
Busulfan
|
Bucelon
|
2 mg
|
Film-Coated Tablet
|
Alkylating Agent (Alkyl sulfonate)
|
Celon Laboratories Private Limited
|
India
|
Initial (from Monitored Release)
|
04 October 2022
|
16 April 2025
|