| View |
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DRP-14728
|
Pregabalin + Mecobalamin
|
Neuronov
|
75 mg / 750 mcg
|
Capsule
|
-
|
Unison Pharmaceuticals Pvt. Ltd. (Unit 1)
|
India
|
Initial
|
15 December 2023
|
15 December 2028
|
| View |
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HRP-633
|
Isopropyl Alcohol
|
Pro-Defense
|
70% Solution
|
Liquid
|
-
|
Medipak Manufacturing, Inc.
|
Philippines
|
Initial
|
17 November 2023
|
17 November 2025
|
| View |
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DRP-14743
|
Ascorbic Acid
|
Cool Fresh
|
1g
|
Powder for Oral Solution (Orange Flavor)
|
-
|
PT Karunia Alam Segar
|
Indonesia
|
Initial
|
20 December 2023
|
20 December 2025
|
| View |
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DRP-14635
|
Pemetrexed (as disodium hemipentahydrate)
|
Prexvid 100
|
100 mg
|
Powder for Concentrate for Solution for Infusion (I.V.)
|
-
|
Qilu Pharmaceutical Hainan Co., Ltd.
|
China
|
Initial (Re-Application)
|
08 November 2023
|
08 November 2028
|
| View |
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HRP-634
|
Povidone-Iodine
|
Betasol
|
7.5% (w/v)
|
Cleansing Solution
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
17 November 2023
|
17 November 2028
|
| View |
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DRP-14661
|
Cyanocobalamin (Vitamin B12)
|
Power B12
|
100 mcg
|
Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
17 November 2023
|
17 November 2025
|
| View |
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DRP-14660
|
Multivitamins.
|
Apcevit®
|
Formulation:
Each capsule contains:
Retinol Acetate (Vitamin A)
1750 IU
Cholecalciferol (Vitamin D3)
400 IU
Pyridoxine Hydrochloride (Vitamin B6) Thiamine Mononitrate (Vitamin B1)
2 mg
1.3 mg
dl-Alpha Tocopheryl Acetate (Vitamin E)
10 IU
Riboflavin (Vitamin B2)
1.3 mg
Ascorbic Acid (Vitamin C)
80 mg
Folic Acid (Vitamin B9)
170 mcg
Niacinamide (Vitamin B3)
20 mg
Cyanocobalamin (Vitamin B12)
5 mcg
|
Capsule
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
17 November 2023
|
17 November 2028
|
| View |
|
DRP-14201
|
Mometasone furoate (as monohydrate)
|
Rinoease
|
50 mcg/ actuation (0.05% w/w)
|
Nasal Spray Suspension.
|
-
|
ICPA Health Products Limited
|
India
|
Initial
|
18 July 2023
|
18 July 2028
|
| View |
|
DR-XY48967
|
Azithromycin (as dihydrate)
|
Romycin
|
200 mg/5 mL
|
Powder for Oral Suspension
|
Antibacterial (Macrolide)
|
The IBN SINA Pharmaceutical Industry Ltd.
|
Bangladesh
|
Initial
|
28 December 2023
|
28 December 2028
|
| View |
|
DRP-14690
|
Ferrous Sulfate + Folic Acid
|
Ferusgen
|
300 mg (equivalent to 90 mg elemental Iron)/250 mcg
|
Film-Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial
|
28 November 2023
|
28 November 2028
|
| View |
|
DRP-14630
|
Sodium Chloride
|
Nasaph-Cl
|
6.5 mg/mL (0.65% w/v)
|
Nasal Drops
|
-
|
Kilitch Drugs (India) Limited
|
India
|
Initial
|
08 November 2023
|
08 November 2028
|
| View |
|
HRP-635
|
Sodium Bicarbonate
|
Bicarbolen
|
325 mg
|
Tablet
|
-
|
Sapphire Lifesciences Pvt., Ltd.
|
India
|
Initial
|
24 November 2023
|
24 November 2028
|
| View |
|
DRP-14631
|
Sodium Chloride
|
Nasaph-Cl
|
6.5 mg/mL (0.65% w/v)
|
Nasal Spray
|
-
|
Kilitch Drugs (India) Limited
|
India
|
Initial
|
08 November 2023
|
08 November 2028
|
| View |
|
DRP-14691
|
Paracetamol + Phenylephrine Hydrochloride +
Chlorphenamine Maleate
|
Biosaph-Plus
|
500 mg/10 mg/2 mg
|
Capsule
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
28 November 2023
|
28 November 2028
|
| View |
|
DRP-14641
|
Lactulose
|
Kleenlac
|
3.35 g/5 mL
|
Syrup.
|
-
|
Nabiqasim Industries (Pvt.) Ltd.
|
Pakistan
|
Initial
|
09 November 2023
|
09 November 2028
|
| View |
|
DR-XY48816
|
Sodium Hyaluronate
|
Optanate
|
1mg/mL (0.1%)
|
Ophthalmic Solution (Eye Drops)
|
-
|
Daewoo Pharm. Co., Ltd.
|
Korea
|
Initial (Reapplication)
|
18 July 2023
|
18 July 2028
|
| View |
|
DR-XY48809
|
Nebivolol (as hydrochloride)
|
Nebstyle 5
|
5mg
|
Tablet
|
-
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
12 July 2023
|
12 July 2028
|
| View |
|
DRP-14627
|
Fluticasone Propionate
|
Thixanase
|
50 mcg/actuation (0.05% w/v)
|
Suspension for Nasal Spray
|
-
|
Biodeal Pharmaceuticals Pvt., Ltd
|
India
|
Initial
|
07 November 2023
|
07 November 2028
|
| View |
|
DR-XY48664
|
Alpha Ketoanalogues + Essential Amino Acids
|
Renalog Ds
|
Formulation
Each film-coated tablet contains:
Calcium-4-methyl-2-oxovalerate (a-ketoanalogue of leucine, calcium salt).
Calcium-3-methyl-2-oxobutyrate (a-ketoanalogue of valine, calcium salt)..
Calcium-2-oxo-3-phenylpropionate (a-ketoanalogue of phenylalanine, calcium salt).
Calcium-3-methyl-2-oxovalerate (a-ketoanalogue of isoleucine, calcium salt)..
202 mg
172 mg
.... 136 mg
134 mg
Calcium-DL-2-hydroxy-4-(methylthio)-butyrate (a-hydroxyanalogue of methionine, calcium salt)... 118 mg
L-Lysine acetate....
L-Threonine.....
L-Histidine..
L-Tyrosine....
L-Tryptophan.....
Total Nitrogen Content..
210 mg
106 mg
76 mg
60 mg
46 mg
72 mg
|
Film-Coated Tablet
|
-
|
Pharose Remedies Limited
|
India
|
Monitored Release
|
04 October 2023
|
04 October 2028
|
| View |
|
DR-XY48876
|
Abiraterone Acetate
|
Arabitro
|
250 mg
|
Tablet
|
-
|
Glenmark Pharmaceuticals Limited
|
India
|
Monitored Release (MR) (Re-application)
|
09 November 2023
|
09 November 2028
|