| View |
|
DRP-11590
|
Omeprazole
(As Sodium)
|
Pharzole
|
40 mg
|
Lyophilized Powder for I.V. Injection
|
-
|
Affy Parenterals
|
India
|
-
|
31 March 2022
|
31 March 2027
|
| View |
|
THPR-58
|
Vitex trifolia (Lagundi Leaf) + Zingiber officinale
(Ginger Rhizome) + Abrus precatorius (Rosary pea Leaf)
+ Phaleria macrocarpa (God's crown Fruit)
|
Herbakof
|
1 g/250 mg/250 mg/200 mg per 15 mL
|
Syrup
|
Traditionally-used Herbal Product: helps relieve cough and soothe throat
|
PT Ferron Par Pharmaceuticals
|
Indonesia
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
DR-XY47891_PI_01.pdf
|
DR-XY47891
|
Ledipasvir + Sofosbuvir
|
Qurled Lp
|
90 mg / 400 mg
|
Film-Coated Tablet
|
Antiviral Combination
|
Strides Shasun Limited
|
India
|
Monitored Release
|
04 April 2022
|
04 April 2027
|
| View |
|
DR-XY 47897
|
Alendronic acid (as Alendronate sodium) +
Cholecalciferol (Vitamin D3)
|
Maxlen-Plus 5600
|
70 mg/5,600 IU
|
Tablet
|
Biphosphonate-Vitamin D Combination
|
Apotex Inc.
|
Canada
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DRP-11618
|
Abiraterone Acetate
|
Abiratred
|
250 mg
|
Film-Coated Tablet
|
Antineoplastic (Hormone Antagonist)
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Monitored Release
|
04 April 2022
|
04 April 2027
|
| View |
|
DR-XY47907
|
Moxifloxacin hydrochloride
|
Moxiwar 400
|
400 mg
|
Film-Coated Tablet
|
Antibacterial
|
Aurobindo Pharma Limited-Unit VII
|
India
|
Initial
|
06 April 2022
|
06 April 2027
|
| View |
|
DRP-11610
|
Dexmedetomidine (as hydrochloride)
|
none
|
100 mcg/mL (200 mcg /2 mL)
|
Concentrate Solution for
Intravenous Infusion
|
Hypnotic/Sedative
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DRP-11577
|
Ceftazidime (As Pentahydrate)
|
Zidmax
|
1g
|
Powder For Injection (I.M./I.V.)
|
Third Generation Cephalosporin
|
Theon Pharmaceuticals Limited
|
India
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
|
DRP-11608
|
Isosorbide Mononitrate
|
Isolyte
|
60 mg
|
Sustained-Release Tablet
|
Antianginal Agent (Organic Nitrate)
|
Fredun Pharmaceuticals Limited
|
India
|
Initial (Rx) correction
|
06 September 2022
|
01 April 2027
|
| View |
DR-XY47888_PI_01.pdf
|
DR-XY47888
|
Olmesartan Medoxomil
|
Alzor
|
20 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
01 April 2022
|
01 April 2027
|
| View |
|
DR-XY47890
|
Montelukast (as sodium) + Levocetirizine hydrochloride
|
Co-Altria Ped
|
5mg/2.5mg
|
Chewable Tablet
|
Leukotriene Receptor Antagonist/Antihistamine
|
Ajanta Pharma Limited
|
India
|
Initial (from Monitored Release) [Reconstruction]
|
03 October 2022
|
01 April 2027
|
| View |
|
DR-XY47889
|
Montelukast (as sodium) + Levocetirizine Hydrochloride
|
Co-Altria Ped
|
5mg/5mg
|
Chewable Tablet
|
Leukotriene Receptor Antagonist/Antihistamine
|
Ajanta Pharma Limited
|
India
|
Initial (from Monitored Release) [Reconstruction]
|
03 October 2022
|
01 April 2027
|
| View |
DR-XY47904_PI_01.pdf
|
DR-XY47904
|
Olmesartan Medoxomil
|
Alzor
|
40 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
05 April 2022
|
05 April 2027
|
| View |
|
DR-XY47902
|
Rosuvastatin (as calcium)
|
Rosucol
|
10 mg
|
Film-Coated Tablet
|
HMG CoA Reductase Inhibitor
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
05 April 2022
|
05 April 2027
|
| View |
|
DR-XY47894
|
Telmisartan
|
Ajesart
|
80 mg
|
Tablet
|
Angiotensin II Receptor Blocker
|
Actavis Ltd.
|
Malta
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DR-XY47895
|
Telmisartan + Hydrochlorothiazide
|
Ajezide
|
80 mg/25 mg
|
Tablet
|
Angiotensin II Receptor Blocker- Diuretic Combination
|
Actavis Ltd.
|
Malta
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
DR-XY47903_PI_01.pdf
|
DR-XY47903
|
Olmesartan Medoxomil) + Amlodipine (as besilate)
|
Alzor CCB
|
20 mg/5 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blockers (ARBs) and Calcium
Channel Blockers
|
Ajanta Pharma Limited
|
India
|
Initial [from Monitored Release status] [Reconstruction]
|
22 December 2022
|
05 April 2027
|
| View |
DR-XY47912_PI_01.pdf
|
DR-XY47912
|
Olmesartan Medoxomil + Amlodipine (as besilate)
|
Alzor CCB
|
20mg / 10mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blockers (ARBs) and Calcium
Channel Blockers
|
Ajanta Pharma Limited
|
India
|
Initial [from Monitored Release status] [Correction]
|
02 September 2022
|
06 April 2027
|
| View |
|
DR-XY47886
|
Aripiprazole
|
Arpivex 10
|
10 mg
|
Orally Disintegrating Tablet
|
Antipsychotic
|
West Coast Pharmaceutical Works Ltd.
|
India
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
DRP-11614_PI_01.pdf
|
DRP-11614
|
Dichlorobenzyl alcohol + Amylmetacresol +
Lidocaine hydrochloride
|
Trosoothe Plus
|
1.2 mg/600 mcg/10 mg
|
Lozenge (Black Currant
Flavor)
|
Antiseptic/ Anesthetic
|
Unique Pharmaceutical Laboratories (A Division of
J.B. Chemicals & Pharmaceuticals Ltd.)
|
India
|
Monitored Release
|
04 April 2022
|
04 April 2027
|