| View |
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DRP-13753
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Carnitine Orotate + Liver Extract + Riboflavin (Vitamin B2) Adenine hydrochloride (Vitamin B4) + Pyridoxine hydrochloride (Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
Inlex
|
300 mg/25 mg/1 mg/5 mg/50 mg/250 mcg
|
Capsule
|
-
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Marnets Pharma Corporation
|
Philippines
|
Initial
|
05 April 2023
|
05 April 2028
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| View |
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DRP-13737
|
Metoclopramide Hydrochloride
|
Metoclosaph
|
1 mg/mL (5 mg/5 mL)
|
Oral Solution
|
-
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Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
03 April 2023
|
03 April 2028
|
| View |
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DR-XY48688
|
Acetated Ringer's Solution
|
None
|
Formulation:
Each 100 mL contains:
Sodium chloride 600 mg
Sodium acetate trihydrate 380 mg
Potassium chloride 30 mg
Calcium chloride dihydrate 20 mg
|
Solution for I.V. Infusion
|
-
|
A.N.B. Laboratories Co., Ltd.
|
Thailand
|
Initial
|
03 April 2023
|
03 April 2028
|
| View |
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DRP-13712
|
Moxifloxacin (as hydrochloride) + Dexamethasone
phosphate (as sodium)
|
Modexeye
|
5 mg/1 mg per mL (0.5% w/v / 0.1% w/v)
|
Ophthalmic Solution
|
-
|
Makcur Laboratories Limited
|
India
|
Initial
|
30 March 2023
|
30 March 2028
|
| View |
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DRP-13710
|
Clobetasol propionate
|
Club
|
500 mcg/g (0.05% w/w)
|
Topical Ointment
|
-
|
Rhydburg Pharmaceuticals Limited
|
India
|
Initial
|
30 March 2023
|
30 March 2028
|
| View |
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DRP-13709
|
Clobetasol propionate
|
Ristac
|
500 mcg/g (0.05% w/w)
|
Topical Ointment
|
-
|
Rhydburg Pharmaceuticals Limited
|
India
|
Initial
|
30 March 2023
|
30 March 2028
|
| View |
|
DR-XY48690
|
Thymalfasin
|
Heri
|
1.6 mg
|
Lyophilized Powder for Injection (SC)
|
-
|
Hainan Zhonghe Pharmaceutical Co., Ltd.
|
China
|
Monitored Release
|
04 April 2023
|
04 April 2028
|
| View |
|
DRP-13716
|
Cefepime (as hydrochloride) (with L-Arginine)
|
Totacef-1000
|
1 g
|
Powder for Injection (I.M./I.V.)
|
-
|
Mankind Pharma Limited (Unit-1)
|
India
|
Initial
|
30 March 2023
|
30 March 2028
|
| View |
|
DRP-13732
|
Acetylcysteine
|
Fluixeine
|
600 mg
|
Effervescent Tablet
|
-
|
Synmosa Biopharma Corporation (Synmosa Plant)
|
Taiwan
|
Initial
|
03 April 2023
|
03 April 2028
|
| View |
|
DR-XY48684
|
Candesartan cilexetil
|
Torcand-32
|
32 mg
|
Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release (MR) (Correction)
|
02 August 2023
|
31 March 2028
|
| View |
|
DRP-13719
|
Dolutegravir (as sodium)
|
None
|
50 mg
|
Film-Coated Tablet
|
Direct Acting Antiviral (Integrase Inhibitor)
|
Sun Pharmaceutical Industries Limited.
|
India
|
Initial (Reconstruction)
|
31 July 2024
|
31 March 2028
|
| View |
|
DR-XY48686
|
Oxaliplatin
|
Rexta
|
5 mg/mL (100 mg/20 mL)
|
Concentrate Solution for I.V.
Infusion
|
-
|
PT. Global Onkolab Farma
|
Indonesia
|
Initial
|
31 March 2023
|
31 March 2025
|
| View |
|
DRP-13718
|
Ascorbic Acid + Zinc
|
Immunavit
|
1 g/10 mg (equivalent to 27.5 mg Zinc sulfate monohydrate) per 5 mL
|
Syrup
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
30 March 2023
|
30 March 2028
|
| View |
|
DRP-13747
|
Phospholipids
|
Saphlipids
|
300 mg
|
Capsule
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
04 April 2023
|
04 April 2028
|
| View |
|
DRP-13717
|
Ascorbic Acid + Colecalciferol (Vitamin D,) + Zinc
|
Saphzeed3-Eff
|
1 g (equivalent to 1124.86 mg Sodium ascorbate) / 400 IU /10 mg (equivalent to 69.92 mg Zinc gluconate)
|
Effervescent Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd..
|
India
|
Initial
|
30 March 2023
|
30 March 2028
|
| View |
|
DR-XY48687
|
Oxaliplatin
|
Rexta
|
5 mg/mL (50 mg/10 mL)
|
Concentrate Solution for I.V.
Infusion
|
-
|
PT. Global Onkolab Farma
|
Indonesia
|
Initial
|
31 March 2023
|
31 March 2025
|
| View |
|
DRP-13745
|
Sodium Bicarbonate
|
None
|
650 mg
|
Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
04 April 2023
|
04 April 2028
|
| View |
|
HRP-589
|
Clove Oil
|
None
|
500 mg per mL
|
Solution (Toothache Drops)
|
-
|
Ace Pharmaceuticals, Inc.
|
Philippines
|
Initial
|
04 April 2023
|
04 April 2025
|
| View |
|
DRP-13741
|
Ferrous fumarate + Folic Acid (Vitamin B9)
|
Feragen Plus Cap
|
181.82 mg (equivalent to 60 mg of elemental Iron)/
400 mcg
|
Capsule
|
-
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial
|
03 April 2023
|
03 April 2028
|
| View |
|
DRP-13739
|
Ferrous sulfate + Folic Acid (Vitamin B9)
|
Ironfer Plus
|
187.50 mg (equivalent to 60 mg of elemental Iron)/ 400 mcg
|
Film-Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial
|
03 April 2023
|
03 April 2028
|