| View |
|
DR-XY29002
|
Ciprofloxacin (As Hydrochloride)
|
Fluxeran
|
500 mg
|
Tablet
|
Antibacterial
|
Lloyd Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
01 September 2022
|
02 October 2026
|
| View |
|
FDA-0585399
|
Calcium + Zinc + Calcitriol
|
Dcal Vita
|
200mg (equivalent to 500mg Calcium Carbonate) / 7.5mg (equivalent to 20.588mg Zinc Sulfate Monohydrate) / 0.25mcg
|
Softgel Capsule
|
-
|
Renown Pharmaceuticals Pvt. Ltd.
|
India
|
Initial (OTC) correcttion
|
06 September 2022
|
19 May 2027
|
| View |
|
BR-1417
|
Adalimumab
|
Idacio
|
40 mg/ 0.8 mL
|
Solution for Injection (SC)
|
Tumor Necrosis Factor Alpha (TNF-a) Inhibitors
|
Merck Serono S.p.A.
|
Italy
|
Monitored Release
|
02 September 2022
|
02 September 2027
|
| View |
|
BR-1416
|
Adalimumab
|
Idacio
|
40 mg/ 0.8 mL
|
Solution for Injection (SC)
|
Tumor Necrosis Factor Alpha (TNF-a) Inhibitors
|
Merck Serono S.p.A.
|
Italy
|
Monitored Release
|
02 September 2022
|
02 September 2027
|
| View |
|
DRP-12547.
|
Cefuroxime (As Axetil)
|
Raxum
|
500 mg
|
Film-Coated Tablet
|
Anti-Infectives (Cephalosphorin)
|
Hiral Labs Limited
|
India
|
Initial
|
31 August 2022
|
31 August 2027
|
| View |
|
THPR-61
|
Pelargonium sidoides Root (South African Geranium
Dry Extract)
|
Kalomin S
|
20 mg
|
Film-Coated Tablet
|
Traditionally-Used Herbal Product: Cough and Cold
Relief
|
Korea United Pharm. Inc.
|
Korea
|
Initial (Correction)
|
17 October 2022
|
30 August 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-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 |
|
DRP-12568
|
Omeprazole (as Sodium)
|
None
|
40 mg
|
Lyophilized Powder for Injection for I.V. Infusion
|
Proton Pump Inhibitor
|
Hainan Brilliant Pharmaceutical Co., Ltd.
|
China
|
Initial
|
07 September 2022
|
07 September 2027
|
| View |
|
DRP-12543
|
Sildenafil (as citrate)
|
Erexil
|
100 mg
|
Film Coated Tablet
|
Phosphodiesterase-5 (PDE5) Inhibitor
|
Akriti Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
30 August 2022
|
30 August 2027
|
| View |
|
DRP-12553
|
Bisoprolol fumarate
|
Bisolab
|
5 mg
|
Film Coated Tablet
|
Alu/Alu blister pack x 10's (Box of 30's)
|
Medisure Laboratories Pakistan (Pvt.) Ltd.
|
Pakistan
|
Initial
|
01 September 2022
|
01 September 2027
|
| View |
BR-1415_PI_01.pdf
|
BR-1415
|
Ustekinumab
|
Stelara
|
45 mg/0.5 mL
|
Solution For Injection (SC)
|
Interleukin Inhibitors
|
Cilag AG
|
Switzerland
|
Initial
|
31 August 2022
|
31 August 2027
|
| View |
|
DRP-12521
|
Propofol
|
Quifol
|
10 mg/mL (1% w/v)
|
Emulsion for I.V. Injection
|
General Anesthetic
|
Aculife Healthcare Private Limited
|
India
|
Initial
|
26 August 2022
|
26 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 |
DRP-12529_PI_01.pdf
|
DRP-12529
|
Levocetirizine dihydrochloride + Montelukast (as
sodium)
|
Monterizine
|
10 mg + 5 mg
|
Capsule
|
Antihistamine + Leukotriene Receptor Antagonist
|
Hanmi Pharmaceutical Co., Ltd.
|
Korea
|
Monitored Release
|
30 August 2022
|
30 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-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-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
|