| View |
|
DR-XY48328
|
Sunitinib (as maleate)
|
Nibsutib
|
12.5 mg
|
Capsule
|
Antineoplastic Agent (Protein Kinase Inhibitor)
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Initial
|
31 August 2022
|
31 August 2027
|
| View |
|
DR-XY48329
|
Meformin hydrochloride + Gliclazide
|
Melanov M OD
|
500 mg/30 mg
|
Sustained - Release Tablet
|
-
|
Micro Labs Limited
|
India
|
Monitored Release (MR)
|
06 September 2022
|
06 September 2027
|
| View |
DR-XY48330_PI_01.pdf
|
DR-XY48330
|
Tenofovir Alefenamide (As Fumarate)
|
HepBest
|
25 mg
|
Film-Coated Tablet
|
-
|
Mylan Laboratories Limited
|
India
|
Monitored Release
|
01 September 2022
|
01 September 2027
|
| View |
|
DR-XY48331
|
Simvastatin
|
Simvacor
|
40 mg
|
Film-Coated Tablet
|
HMG CoA reductase inhibitor
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
01 September 2022
|
01 September 2027
|
| View |
DR-XY48332_PI_01.pdf
|
DR-XY48332
|
Erdafitinib
|
Balversa
|
5 mg
|
Film-Coated Tablet
|
Antineoplastic Agent [Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor]
|
Janssen Cilag S.p.A
|
Italy
|
Monitored Release
|
01 September 2022
|
01 September 2027
|
| View |
|
DR-XY48333
|
Doripenem (as monohydrate)
|
Dorpen
|
500mg
|
Powder for Injection for I.V. Infusion
|
Antibacterial (Carbapenem)
|
Brooks Steriscience Limited
|
India
|
Initial
|
01 September 2022
|
01 September 2027
|
| View |
|
DR-XY48334
|
Cefoperazone + Sulbactam
|
Xefrizil
|
500 mg/500 mg
|
Powder for Injection (I.V./I.M.)
|
Antibacterial (Cephalosporin/Beta-Lactamase
Inhibitor)
|
Vellinton Healthcare
|
India
|
Initial
|
14 September 2022
|
14 September 2027
|
| View |
|
DR-XY48335
|
Clobazam
|
Yogazam
|
10 mg
|
Tablet
|
Anxiolytic (Benzodiazepine derivative)
|
Micro Labs Limited
|
India
|
Monitored Release (Re-application)
|
02 September 2022
|
02 September 2027
|
| View |
|
DR-XY48336
|
Clobazam
|
Yogazam
|
20 mg
|
Tablet
|
-
|
Micro Labs Limited
|
India
|
Monitored Release (Re-application)
|
02 September 2022
|
02 September 2027
|
| View |
DR-XY48337_PI_01.pdf
|
DR-XY48337
|
Erdafitinib
|
Balversa
|
4 mg
|
Film-Coated Tablet
|
Antineoplastic Agent [Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor]
|
Janssen Cilag S.p.A
|
Italy
|
Monitored Release
|
02 September 2022
|
02 September 2027
|
| View |
DR-XY48338_PI_01.pdf
|
DR-XY48338
|
Erdafitinib
|
Balversa
|
3 mg
|
Film-Coated Tablet
|
-
|
Janssen Cilag S.p.A
|
Italy
|
Monitored Release (Correction)
|
28 September 2023
|
02 September 2027
|
| View |
|
DR-XY48339
|
Thiocolchicoside
|
Thiozz-8
|
8 mg
|
Orodispersible Tablet
|
Muscle Relaxant
|
Ipca Laboratories Ltd.
|
India
|
Monitored Release
|
06 September 2022
|
06 September 2027
|
| View |
|
DR-XY48340
|
Vitamin B-Complex + Choline Bitartrate + Inositol
|
Balanced B-50
|
Formulation Each tablet contains:
Choline Bitartrate-50 mg D-Calcium Pantothenate-50 mg Inositol Niacinamide (Vitamin B3)-50 mg Pyridoxine hydrochloride (Vitamin B6)-50 mg
Riboflavin (Vitamin B2)-50 mg
Thiamin Mononitrate-50 mg Biotin (Vitamin B7)-50 mcg Cyanocobalamin (Vitamin B12)-50 mcg Folic Acid-400mcg
|
Tablet
|
Vitamins and Minerals
|
Nexgen Pharma, Inc.
|
United States of America
|
Initial
|
12 September 2022
|
12 September 2027
|
| View |
DR-XY48341_PI_01.pdf
|
DR-XY48341
|
Pretomanid
|
Dovprela
|
200 mg
|
Tablet
|
Antimycobacterial
|
Mylan Laboratories Limited
|
India
|
Monitored Release (MR)
|
06 September 2022
|
06 September 2027
|
| View |
|
DR-XY48342
|
Memantine Hydrochloride
|
Memry
|
10 mg / mL
|
Oral Solution
|
Anti-Dementia
|
Chanelle Medical
|
Ireland
|
Monitored Release
|
07 September 2022
|
07 September 2027
|
| View |
|
DR-XY48343
|
Roxadustat
|
Evrenzo
|
50 mg
|
Film-Coated Tablet
|
-
|
Catalent Pharma Solutions LLC
|
United States of America
|
Monitored Release
|
08 September 2022
|
08 September 2027
|
| View |
|
DR-XY48344
|
Roxadustat
|
Evrenzo
|
20 mg
|
Film-Coated Tablet
|
-
|
Catalent Pharma Solutions LLC
|
United States of America
|
Monitored Release
|
08 September 2022
|
08 September 2027
|
| View |
DR-XY48345_PI_01.pdf
|
DR-XY48345
|
Zanubrutinib
|
Brukinsa
|
80 mg
|
Capsule
|
Bruton's Tyrosine Kinase (BTK) Inhibitor
|
Catalent CTS, LLC
|
United States of America
|
Monitored Release
|
08 September 2022
|
08 September 2027
|
| View |
|
DR-XY48346
|
Midazolam (as Hydrochloride)
|
Dormizin
|
5 mg/mL (15 mg/3 mL)
|
Solution for Injection (IM/IV)
|
Hypnotic and Sedative (Benzodiazepine derivative)
|
Ciron Drugs & Pharmaceuticals Pvt. Limited
|
India
|
Initial
|
12 September 2022
|
12 September 2027
|
| View |
|
DR-XY48347
|
Leflunomide
|
Bageda
|
20mg
|
Film-Coated Tablet
|
-
|
World Medicine İlaç Sanayi Ve Ticaret A.Ş.
|
Turkey
|
Monitored Release
|
12 September 2022
|
12 September 2027
|