| View |
|
DRP-11867
|
Iron
|
Regifer
|
104.84 mg (equivalent to 325 mg Ferrous Sulfate)
|
Tablet
|
Anti-anemic
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (OTC)
|
16 May 2022
|
16 May 2027
|
| View |
|
DRP-11895
|
Cholecalciferol (Vitamin D3
|
VitasaphD3-1000
|
1000 IU
|
Film-Coated Tablet
|
Vitamin
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (OTC)|Correction]
|
27 May 2022
|
18 May 2027
|
| View |
|
DRP-11738
|
Cetirizine Dihydrochloride
|
Rextizine-D
|
10 mg
|
Film-Coated Tablet
|
-
|
Next Wave (India)
|
India
|
Initial (OTC)
|
17 May 2022
|
17 May 2027
|
| View |
|
DRP-11737
|
Cetirizine Hydrochloride
|
Rextizine
|
10 mg
|
Film-Coated Tablet
|
-
|
Next Wave (India)
|
India
|
Initial (OTC)
|
17 May 2022
|
17 May 2027
|
| View |
|
DRP-11870
|
Clotrimazole
|
Clotrimarex
|
10 mg/g (1% w/w)
|
Topical Cream
|
Antifungal
|
Next Wave (India)
|
India
|
Initial (OTC)
|
12 May 2022
|
12 May 2027
|
| View |
|
DRP-11868
|
Bisacodyl
|
Bisarex
|
5mg
|
Tablet
|
Laxative
|
Next Wave (India)
|
India
|
Initial (OTC)
|
17 May 2022
|
17 May 2027
|
| View |
|
DRP-11869
|
Diclofenac
|
Quickier
|
10 mg/g (1% w/w) (equivalent to 11.6 mg
|
Topical Gel
|
Non-Steroidal Anti-Inflammatory Drug (Nsaid)
|
Fredun Pharmaceuticals Ltd.
|
India
|
Initial (OTC)
|
12 May 2022
|
12 May 2027
|
| View |
|
DRP-11881
|
Atorvastatin (As Calcium)
|
Fredtor
|
10mg
|
Film Coated Tablets
|
HMG COA Reductase Inhibitor
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
18 May 2022
|
18 May 2027
|
| View |
|
DRP-11880
|
Atorvastatin (As Calcium)
|
Fredtor
|
20mg
|
Film Coated Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
18 May 2022
|
18 May 2027
|
| View |
|
DRP-11879
|
Atorvastatin (As Calcium)
|
Fredtor
|
40mg
|
Film Coated Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
18 May 2022
|
18 May 2027
|
| View |
|
DRP-11877
|
Mannitol
|
Diuretol
|
20g/100 mL (20%)
|
Solution for Injection (IV)
|
Osmotic Diuretic
|
Althea Pharma Pvt. Ltd.
|
India
|
Initial Reconstruction]
|
27 April 2023
|
13 May 2027
|
| View |
|
DRP-11878
|
Atorvastatin (As Calcium)
|
Fredtor
|
80mg
|
Film Coated Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial (Correction)
|
26 July 2022
|
18 May 2027
|
| View |
|
FDA-0570474
|
Calcium + Zinc + Calcitriol
|
Dcal Vita
|
200mg (equivalent to 500mg Calcium Carbonate) / 7.5mg (equivalent to 20.588mg Zinc Sulfate Monohydrate) / 0.25mcg
|
Softgel Capsule
|
Minerals / Vitamin
|
Renown Pharmaceuticals Pvt. Ltd.
|
India
|
Initial (OTC)
|
19 May 2022
|
19 May 2027
|
| View |
|
DRP-11894
|
Montelukast (as sodium) + Levocetirizine hydrochloride
|
Respiz
|
10 mg / 5 mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist-Antihistamine
Combination
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
17 May 2022
|
17 May 2027
|
| View |
|
DRP-11886
|
Multivitamins
|
Maxxi Nerve
|
Formulation Thiamine Mononitrate (Vitamin B1)-300mg Pyridoxine Hydrochloride (Vitamin B6)-100mg Cyanocobalamin (Vitamin B12)-1mg di-Alpha Tocopheryl Acetate (Vitamin E)-200mg
|
Film-Coated Tablet
|
Vitamin
|
J.M. Tolmann Laboratories Inc.
|
Philippines
|
Initial (OTC) (Variation: PCPR Conversion)
|
16 May 2022
|
04 November 2026
|
| View |
|
DR-XY480312
|
Permethrin
|
None
|
50 mg/mL (5%)
|
Lotion
|
Scabicide/Pediculoside
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (OTC]
|
20 May 2022
|
20 May 2027
|
| View |
|
DR-XY48018
|
Tegoprazan
|
K-Cab
|
50 mg
|
Film-Coated Tablet
|
Proton Pump Inhibitor
|
HK Inno.N Corporation
|
Korea
|
Monitored Release
|
18 May 2022
|
18 May 2025
|
| View |
|
DRP-11891
|
Imipenem + Cilastatin
|
Seamilast
|
500mg/500mg
|
Powder for Injection (IV)
|
-
|
Brooks Laboratories Limited
|
India
|
Initial
|
17 May 2022
|
17 May 2027
|
| View |
|
DRP-11922
|
Paracetamol + Phenylephrine HCl + Chlorphenamine Maleate
|
Biosaph
|
500 mg/10 mg/2 mg
|
Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (OTC) (Correction)
|
14 November 2023
|
20 May 2027
|
| View |
|
DRP-11918
|
Dobutamine (as Hydrochloride)
|
Bildobex 50
|
50mg/mL
|
Solution for Intravenous (IV) Infusion
|
Adrenergic and Dopaminergic Agent
|
MACKUR LABORATORIES LIMITED
|
India
|
Initial
|
20 May 2022
|
20 May 2027
|