| View |
DR-XY48307_PI_01.pdf
|
DR-XY48307
|
Nepafenac
|
Optanep
|
3 mg/ mL (0.3% w/v)
|
Sterile Ophthalmic Suspension
|
Non-Steroidal Anti-Inflammatory Drug
|
World Medicine Ilaç Sanayi ve Ticaret A.Ş.
|
Turkey
|
Monitored Release
|
22 August 2022
|
22 August 2027
|
| View |
|
DR-XY48308
|
Escitalopram (As Oxalate)
|
Escit
|
10mg
|
Film Coated Tablet
|
-
|
Celogen Generics Private Ltd.
|
India
|
Initial
|
22 August 2022
|
22 August 2027
|
| View |
|
DR-XY48310
|
Pegaspargase
|
Oncaspar
|
750 U/mL
|
Powder for Solution for Injection/ Infusion
(IV/IM)
|
Antineoplastic
|
Lyophilization Services of New England Inc.
|
United States of America
|
Monitored Release
|
23 August 2022
|
23 August 2027
|
| View |
|
DR-XY48311
|
Bupropion Hydrochloride
|
Bupron XL 300
|
300 mg
|
Extended Release Tablet
|
Anti-depressant
|
Sun Pharmaceutical Industries Limited.
|
India
|
Monitored Release (Variation) (Reconstruction)
|
31 July 2024
|
25 August 2027
|
| View |
|
DR-XY48312
|
Bupropion Hydrochloride
|
Bupron XL 150
|
150 mg
|
Extended Release Tablet
|
Anti-depressant
|
Sun Pharmaceuticals Industries Limited
|
India
|
Monitored Release (Variation) (Reconstruction)
|
31 July 2024
|
25 August 2027
|
| View |
|
DR-XY48313
|
Paclitaxel
|
None
|
6 mg/ mL (100 mg/16.7 mL)
|
Solution for Injection (IV Infusion)
|
-
|
Eskayef Pharmaceuticals Limited - Rupganj Plant
|
Bangladesh
|
Initial
|
08 August 2022
|
08 August 2027
|
| View |
|
DR-XY48314
|
Paclitaxel
|
None
|
6 mg/mL (300 mg/50 mL)
|
Solution for Injection
(IV Infusion)
|
Antineoplastic Agent (Taxane)
|
Eskayef Pharmaceuticals Limited - Rupganj Plant
|
Bangladesh
|
Initial
|
25 August 2022
|
25 August 2027
|
| View |
|
DR-XY48315
|
Mesalazine
|
Mecolzine
|
500 mg
|
Rectal Suppository
|
Intestinal Antiinflammatory Agent
|
Laboratorios Vitoria, S.A.
|
Portugal
|
Monitored Release
|
26 August 2022
|
26 August 2027
|
| View |
|
DR-XY48316
|
Fosfomycin (as trometamol)
|
Fosmol
|
3 g
|
Granules For Oral Solution
|
Antibacterial
|
Labiana Pharmaceuticals, S.1. U
|
Spain
|
Initial (Re-Application)
|
26 August 2022
|
26 August 2027
|
| View |
DR-XY48317_PI_01.pdf
|
DR-XY48317
|
Tadalafil
|
Torfil 20
|
20 mg
|
Film-Coated Tablet
|
Phosphodiesterase Type 5 (PDE5) Inhibitor
|
Torrent Pharmaceuticals Ltd.
|
india
|
Initial
|
26 August 2022
|
26 August 2027
|
| View |
DR-XY48318_PI_01.pdf
|
DR-XY48318
|
Lamivudine
|
Heptavir Os
|
10 mg/mL
|
Oral Solution
|
Antiviral (Nucleoside/Nucleotide Reverse
Transcriptase Inhibitor)
|
Hetero Labs Limited (Unit III)
|
India
|
Monitored Release
|
26 August 2022
|
26 August 2025
|
| View |
|
DR-XY48319
|
Levetiracetam
|
Levipil XR 1500
|
1.5 g
|
Extended Release Tablet
|
Antiepileptic
|
Sun Pharmaceutical Industries Limited
|
India
|
Monitored Release (MR) (Reconstruction)
|
22 May 2024
|
30 August 2027
|
| View |
|
DR-XY48320
|
Levetiracetam
|
Levipil XR 1000
|
1 g
|
Extended Release Tablet
|
Antiepileptic
|
Sun Pharmaceutical Industries Limited
|
India
|
Monitored Release (MR) (Reconstruction)
|
22 May 2024
|
31 August 2027
|
| View |
|
DR-XY48321
|
Mecobalamin
|
Meconerv
|
1.5 mg
|
Film-Coated Tablet
|
Vitamin
|
Micro Labs Limited
|
India
|
Initial
|
30 August 2022
|
30 August 2027
|
| View |
|
DR-XY48322
|
Mecobalamin
|
Meconerv
|
1 mg
|
Film-Coated Tablet
|
Vitamin
|
Micro Labs Limited
|
India
|
Initial
|
30 August 2022
|
30 August 2027
|
| View |
|
DR-XY48323
|
Methylcobalamine
|
Meconerv
|
500 mg
|
Film-Coated Tablet
|
Vitamin
|
Micro Labs Limited
|
India
|
Initial
|
30 August 2022
|
30 August 2027
|
| View |
DR-XY48324_PI_01.pdf
|
DR-XY48324
|
Tadalafil
|
Torfil 10
|
10 mg
|
Film-Coated Tablet
|
Phosphodiesterase Type 5 (PDE5) Inhibitor
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
30 August 2022
|
30 August 2027
|
| View |
|
DR-XY48325
|
Naratriptan (as hydrochloride)
|
Nargraine
|
2.5 mg
|
Film-Coated Tablet
|
Antimigraine (Selective serotonin (5-HT1] Receptor Agonists
|
Chanelle Medical
|
Ireland
|
Monitored Release
|
31 August 2022
|
31 August 2027
|
| View |
DR-XY48326_PI_01.pdf
|
DR-XY48326
|
Tadalafil
|
Torfil 2.5
|
2.5 mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
india
|
Monitored Release
|
31 August 2022
|
31 August 2027
|
| View |
|
DR-XY48327
|
Methocarbamol + Paracetamol
|
Distem
|
380mg/300mg
|
Tablet
|
Centrally Acting Muscle Relaxant and Antipyretic
|
FAES Farma, S.A.
|
Spain
|
Monitored Release
|
31 August 2022
|
31 August 2027
|