| View |
|
DRP-11985
|
Ascorbic Acid + Zinc + Cholecalciferol (Vitamin D3)
|
Ascorwell
|
500 mg (equivalent to 562.43 mg Sodium
Ascorbate)/10 mg (equivalent to 70 mg Zinc
Gluconate)/1,000 IU
|
Capsule
|
-
|
Mascot Health Series Pvt. Ltd.
|
India
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DRP-11936
|
Paracetamol + Phenylpropanolamine Hydrochloride +
Chlorphenamine Maleate
|
Saphflu-Plus
|
125 mg/ 6.25 mg/0.5 mg per 5 mL
|
Syrup
|
Analgesic/Antipyretic/Decongestant/Antihistamine
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial (OTC)
|
20 May 2022
|
20 May 2027
|
| View |
|
DRP-11937
|
Paracetamol + Phenylpropanolamine Hydrochloride +
Chlorphenamine Maleate
|
Flusaph-Plus
|
125 mg/ 6.25 mg/ 0.5mg per 5 mL
|
Syrup
|
Analgesic/Antipyretic/Decongestant/Antihistamine
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial (OTC) correction
|
06 June 2022
|
20 May 2027
|
| View |
BR-1403_PI_01.pdf
|
BR-1403
|
Bevacizumab
|
Abevmy
|
100 mg / 4mL (25 mg/mL)
|
Concentrate For Solution Fo Infusion (IV)
|
Vascular Endothelial Growth Factor Inhibitors
|
Biocon Limited
|
India
|
Initial (Reconstruction)
|
14 March 2023
|
23 May 2027
|
| View |
BR-1402_PI_01.pdf
|
BR-1402
|
Bevacizumab
|
Abevmy
|
400 mg / 16 mL (25 mg/mL)
|
Vascular Endothelial Growth Factor Inhibitors
|
Vascular Endothelial Growth Factor Inhibitors
|
Biocon Limited
|
India
|
Initial (Reconstruction)
|
15 March 2023
|
23 May 2027
|
| View |
|
DRP-11999
|
Meropenem
|
Unomero 1000
|
1g
|
Powder for Injection (I.V.)
|
-
|
Akums Drugs & Pharmaceuticals Ltd. (Plant III - Injectables)
|
India
|
Initial
|
27 May 2022
|
27 May 2027
|
| View |
|
DR-XY 48036
|
Mosapride citrate (as dihydrate)
|
Gastiin CR
|
15 mg
|
Controlled-Release Tablet
|
Drug for Functional Gastrointestinal El Disorders (Propulsive)
|
Korea United Pharm. Inc.
|
Korea
|
Monitored Release
|
25 May 2022
|
25 May 2027
|
| View |
|
DR-XY48057
|
Losartan potassium + Hydrochlorothiazide
|
Medlosar-Plus 25
|
100mg/25mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB)/Diuretic
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
27 May 2022
|
27 May 2027
|
| View |
|
DR-XY48027
|
Calcifediol
|
Hidroferol
|
266 mcg Softgel Capsule (equivalent to 15,960 IU of Vitamin D
|
Softgel Capsule
|
Vitamin D Analogue
|
HC Clover Productos Y Servicios S.L.
|
Spain
|
Monitored Release
|
20 May 2022
|
20 May 2027
|
| View |
|
DRP-11971
|
Montelukast (as sodium) + Levocetirizine hydrochloride
|
Glemont L
|
10 mg/ 5 mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist-Antihistamine
Combination
|
Glenmark Pharmaceuticals Limited
|
India
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DR-XY48072
|
Pregabalin + Methylcobalamin (Vitamin B12)
|
Neurica-M 75
|
75 mg/750 mcg
|
Capsule
|
Antiepileptics
|
Micro Labs Limited
|
India
|
Monitored Release
|
28 June 2022
|
28 June 2027
|
| View |
|
DR-XY48071
|
Pregabalin + Methylcobalamin (Vitamin B12)
|
Neurica-M 150
|
150 mg/750 mcg
|
Capsule
|
Antiepileptics
|
Micro Labs Limited
|
India
|
Monitored Release
|
28 June 2022
|
28 June 2027
|
| View |
|
DR-XY48054
|
Lidocaine Hydrochloride
|
Lignovell
|
20 mg/mL (2% w/v)
|
Solution for Injection (IV)
|
Local Anaesthetic
|
Pt. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial (Correction)
|
23 June 2022
|
26 May 2027
|
| View |
|
DRP-11962
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Sulpi-1500
|
1 g/500 mg
|
Powder for Injection (I.M./I.V.)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
24 May 2022
|
24 May 2027
|
| View |
|
DRP-11952
|
Lactated Ringer's
|
Ringel
|
Formulation: Each 100 mL contains: Sodium chloride....................600 mg Potassium Chloride...............40 mg Calcium Chloride Dihydrate.... 27 mg Sodium lactate.................320 mg
|
Solution for I.V. Infusion
|
Rehydration Solution
|
Shijiazhuang No.4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
23 May 2022
|
23 May 2027
|
| View |
|
DRP-11943
|
Pantoprazole
|
Praziem
|
40mg
|
Delayed-Release Capsule
|
Proton pump inhibitor
|
Zim Laboratories Limited
|
India
|
Initial
|
23 May 2022
|
23 May 2027
|
| View |
|
DR-XY48056
|
Phenylephrine (as hydrochloride)
|
Phenylalpha
|
50 mcg/mL (500 mcg/10 mL)
|
Solution for I.V. Injection
|
Adrenergic/Dopaminergic Agent
|
Laboratoire Aguettant
|
France
|
Initial
|
27 May 2022
|
27 May 2027
|
| View |
|
DR-XY48042
|
Paricalcitol
|
Parical
|
5 mcg/mL
|
Solution for Injection (IV)
|
Other Anti-Parathyroid Agents
|
Pharmathen SA
|
Greece
|
Monitored Release
|
25 May 2022
|
25 May 2027
|
| View |
|
DR-XY48041
|
Paricalcitol
|
Parical
|
2 mcg/mL
|
Solution for Injection (IV)
|
Other Anti-Parathyroid Agents
|
Pharmathen SA
|
Greece
|
Monitored Release
|
25 May 2022
|
25 May 2027
|
| View |
|
DRP-11967
|
Losartan Potassium
|
None
|
100 mg
|
Film-Coated Tablet
|
Angiotensin II receptor blocker (ARB)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
25 May 2022
|
25 May 2027
|