| View |
|
DRP-14868
|
Ketoconazole
|
Ketazflox
|
20 mg/g (2% w/w)
|
Topical Cream.
|
-
|
Daiwik Pharmasphere Pvt. Ltd.
|
India
|
Initial |OTC]
|
25 January 2024
|
25 January 2029
|
| View |
|
DRP-14869
|
Ketoconazole
|
Ketma
|
20mg/g (2% w/w)
|
Topical Cream
|
-
|
Rhydburg Pharmaceuticals Ltd.
|
India
|
Initial [OTC]
|
25 January 2024
|
25 January 2029
|
| View |
|
DRHR-2330
|
Isopropyl Alcohol
|
Pluscare
|
70 mL (70% v/v)
|
Solution
|
-
|
Jovash International, Inc.
|
Philippines
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DRP-14861
|
Salbutamol (as sulfate)
|
Butaprev
|
1 mg/mL (2.5 mg/2.5 mL)
|
Solution for Nebulization.
|
Antiasthma
|
Cipla Ltd. - Unit I
|
India
|
Initial (Correction)
|
26 July 2024
|
25 January 2029
|
| View |
|
DRP-14860
|
Salbutamol (as sulfate) + Ipratropium bromide.
|
none
|
2.5 mg/ 500 mcg per 2.5 mL
|
Solution for Nebulization
|
-
|
Cipla Limited (Unit I)
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DRP-14865
|
0.9% Sodium Chloride
|
0.9% Sodchlorsaph
|
900 mg/100 mL (0.9% w/v)
|
Solution for IV Infusion
|
-
|
Althea Pharma Pvt. Ltd.
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DR-XY48986
|
Rasagiline (as mesilate)
|
Rasator 1
|
1 mg
|
Tablet
|
-
|
TORRENT PHARMACEUTICALS LTD.
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DRP-14862
|
Tranexamic Acid
|
Clotranex
|
100 mg/mL
|
Solution for Injection (IV)
|
-
|
Gland Pharma Limited
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DR-XY48985
|
Oxaliplatin
|
Doxatin
|
50 mg
|
Lyophilized Powder for Injection (IV Infusion)
|
-
|
Cisen Pharmaceutical Co., Ltd.
|
China
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DRP-14871
|
Clindamycin (as phosphate)
|
Dalinc
|
150 mg/mL (600 mg/4 mL)
|
Solution for Injection
(IM/IV)
|
Antibacterial (Lincosamide)
|
Cisen Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
16 May 2024
|
26 January 2029
|
| View |
|
BRP-135
|
Trastuzumab
|
Trastumed
|
440 mg
|
Lyophilized Powder for Solution for Infusion (IV)
|
-
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DRP-14805
|
Diltiazem Hydrochloride
|
Diltimax
|
60mg
|
Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DRP-14806
|
Diltiazem Hydrochloride
|
Diltimax
|
30mg
|
Tablet
|
-
|
Fredun Pharmaceuticals Limited.
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DRP-14804
|
Isosorbide mononitrate
|
Isolyte
|
30mg
|
Sustained-Release Tablets
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DRP-14874
|
Cisplatin
|
None
|
1 mg/mL
|
Solution for IV Infusion
|
-
|
Venus Remedies Limited
|
India
|
Initial
|
29 January 2024
|
29 January 2029
|
| View |
|
DR-XY48987
|
0.9% Sodium Chloride
|
Visoline
|
9 mg/mL (0.9% w/v)
|
Solution for IV Infusion
|
-
|
Vision Pharmaceuticals
|
Pakistan
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DRP-14873
|
Norepinephrine (as bitartrate monohydrate)
|
Centranor
|
1 mg/mL (4 mg/4 mL)
|
Concentrate for Solution for I.V. Infusion
|
-
|
Mefar İlaç San. A.Ş.
|
Turkey
|
Initial
|
26 January 2024
|
26 January 2029
|
| View |
|
DR-XY48993
|
Oseltamivir (as phosphate)
|
None
|
75 mg
|
Capsule
|
-
|
Korea United Pharm. Inc.
|
Korea
|
Initial
|
26 January 2024
|
26 January 2029
|
| View |
|
DR-XY48992
|
Nepafenac
|
Neypac
|
1 mg/mL (0.1% w/v)
|
Sterile Ophthalmic Suspension (Eye Drops)
|
-
|
Axa Parenterals Limited
|
India
|
Initial
|
26 January 2024
|
26 January 2029
|
| View |
|
DR-XY48991
|
Pantoprazole (as sodium sesquihydrate)
|
Porsprazole
|
40mg
|
Lyophilized Powder for Injection (I.V.)
|
-
|
Med Biopharm Pvt. Ltd.
|
India
|
Initial
|
26 January 2024
|
26 January 2029
|