| View |
|
DRP-15856
|
Risperidone
|
Rispernov 2
|
2 mg
|
Film-Coated Tablet
|
Antipsychotic
|
Cubit Lifesciences LLP
|
india
|
Initial
|
24 September 2024
|
24 September 2029
|
| View |
|
DRP-15859
|
Mesalazine
|
Mesadian 1000
|
1g
|
Rectal Suppository
|
Intestinal Anti-inflammatory Agent
|
Meridian Enterprises Pvt. Ltd.
|
India
|
Initial
|
24 September 2024
|
24 September 2029
|
| View |
|
DR-XY49236
|
Menthol
|
Vicks VapoDrops Xtra Strong
|
21 mg
|
Lozenge (Honey Menthol Flavor)
|
Antiseptic (Throat Preparations)
|
Unique Pharmaceuticals Laboratories (Division of J.B. Chemicals & Pharmaceuticals LTD.)
|
india
|
Initial [OTC]
|
26 September 2024
|
26 September 2029
|
| View |
|
DR-XY49235
|
Menthol
|
Vicks VapoDrops Xtra Strong
|
21 mg
|
Lozenge (Lemon Menthol Flavor)
|
Antiseptic (Throat Preparations)
|
Unique Pharmaceuticals Laboratories (Division of J.B. Chemicals & Pharmaceuticals LTD.)
|
india
|
Initial [OTC]
|
26 September 2024
|
26 September 2029
|
| View |
|
DRP-15860
|
Amitriptyline hydrochloride
|
Tridep
|
25 mg
|
Film-Coated Tablet
|
Antidepressant (Non-Selective Monoamine Reuptake
Inhibitor)
|
Baroque Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
24 September 2024
|
24 September 2029
|
| View |
|
DR-XY49234
|
Menthol
|
Vicks VapoDrops Xtra Strong
|
21 mg
|
Lozenge (Lemon Menthol Flavor)
|
Antiseptic (Throat Preparations)
|
Unique Pharmaceuticals Laboratories (Division of
J.B. Chemicals & Pharmaceuticals LTD.)
|
India
|
Initial [OTC]
|
26 September 2024
|
26 September 2029
|
| View |
|
DR-XY49232
|
Ascorbic Acid
|
Immunec
|
500 mg
|
Capsule
|
Vitamin
|
Hizon Laboratories, Inc.
|
Philippines
|
Renewal
|
25 September 2024
|
14 November 2028
|
| View |
|
DR-XY49220
|
Meropenem (as trihydrate)
|
Vopenem
|
1g
|
Powder for Solution for Injection (IV)
|
Antibacterial (Carbapenem)
|
Venus Remedies Limited
|
India
|
Initial
|
24 September 2024
|
24 September 2029
|
| View |
|
DRP-15423
|
Atorvastatin (as calcium) + Amlodipine (as besilate)
|
Amlog Plus
|
20 mg/5 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitor (Lipid Modifying
Agents)/ Calcium Channel Blocker
|
Fredun Pharmaceuticals Limited
|
india
|
Initial (Re-application)
|
20 September 2024
|
20 September 2029
|
| View |
|
DRP-15422
|
Atorvastatin (as calcium) + Amlodipine (as besilate)
|
Amlog Plus
|
10 mg/10 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitor (Lipid Modifying
Agents)/ Calcium Channel Blocker
|
Fredun Pharmaceuticals Limited
|
India
|
Initial (Re-application)
|
24 September 2024
|
24 September 2029
|
| View |
|
DRP-15899
|
Calcium
|
None
|
500 mg
|
Tablet
|
Mineral
|
Factors Group of Nutritional Companies Inc.
|
Canada
|
Initial
|
26 September 2024
|
26 September 2029
|
| View |
|
DRP-15838
|
Telmisartan
|
Beisartan
|
40 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
20 September 2024
|
20 September 2029
|
| View |
|
DR-XY49226
|
Amlodipine (as besilate) + Valsartan + Rosuvastatin
(as calcium)
|
Exone-R
|
5 mg/80 mg/10 mg
|
Film Coated Tablet
|
Antihypertensive(Angiotensin ReceptorBlocker/Calcium Channel Blocker/HMG Coa Reductaste inhibitor
|
HK Inno.N Corporation
|
Korea
|
Monitored Release (MR)
|
24 September 2024
|
24 September 2029
|
| View |
|
DR-XY49225
|
Amlodipine (as besilate) + Valsartan + Rosuvastatin (as calcium)
|
Exone-R
|
5 mg/160 mg/5 mg
|
Film Coated Tablet
|
Antihypertensive
|
HK Inno. N Corporation
|
Korea
|
Monitored Release(MR)
|
24 September 2024
|
24 September 2029
|
| View |
|
DR-XY49224
|
Amlodipine (as besilate) + Valsartan + Rosuvastatin (as calcium)
|
Exone-R
|
5 mg/160 mg/10 mg
|
Film Coated Tablet
|
Antihypertensive (Angiotensin II Receptor Blocker/Calcium Channel Blocker/HMG Coa reductase inhibitor)
|
HK Inno.N Corporation
|
Korea
|
Monitored Release(MR)
|
24 September 2024
|
24 September 2029
|
| View |
|
DR-XY49227
|
Amlodipine (as besilate) + Valsartan + Rosuvastatin
(as calcium)
|
Exone-R
|
5 mg/80 mg/5 mg
|
Film Coated Tablet
|
Antihypertensive (Angiotensin II Receptor Blocker/Calcium Channel Blocker/ HMG Coa reductase inhibitor)
|
HK Inno.N Corporation
|
Korea
|
Monitored Release (MR)
|
24 September 2024
|
24 September 2029
|
| View |
|
DRP-15858
|
Levofloxacin (as hemihydrate)
|
Leviflex
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Fluoroquinolone)
|
Unison Pharmaceuticals Pvt. Ltd
|
India
|
Initial
|
24 September 2024
|
24 September 2029
|
| View |
|
DRP-15855
|
Tobramycin (as sulfate) + Dexamethasone sodium
phosphate
|
Tobrazin Plus
|
3 mg/1 mg (0.3% / 0.1%) per mL
|
Ophthalmic Solution
(Drops)
|
Antibacterial/Corticosteroid
|
Scott-Edil Pharmacia Ltd.
|
India
|
Initial
|
25 September 2024
|
25 September 2029
|
| View |
|
DRP-15875
|
Tobramycin (as sulfate)
|
Tobidina
|
3 mg/mL (0.3% w/v)
|
Ophthalmic Solution
|
Antibacterial
|
Indiana Ophthalmics.
|
India
|
Initial
|
25 September 2024
|
25 September 2029
|
| View |
|
DRP-15852
|
Losartan Potassium + Hydrochlorothiazide
|
Losanov Plus
|
50 mg/12.5 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB) and Diuretic
|
AMN Life Pvt. Ltd.
|
India
|
Initial
|
23 September 2024
|
23 September 2029
|