| View |
|
DR-XY48714
|
Gadoteric Acid
|
Clariscan
|
0.5 mmol/mL (equivalent to 279.32 mg/mL)
|
Solution for Injection (I.V.)
|
-
|
GE Healthcare AS - Oslo Plant
|
Norway
|
Initial
|
28 April 2023
|
28 April 2028
|
| View |
|
DRP-13858
|
Ascorbic Acid + Zinc
|
None
|
500 mg (equivalent to 568.18 mg Sodium Ascorbate) / 10
mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
03 May 2023
|
03 May 2028
|
| View |
|
DRHR-2247
|
Sulfur
|
Sapflur
|
100 mg/g (10% w/w)
|
Topical Ointment
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
04 May 2023
|
04 May 2028
|
| View |
|
DRP-13877
|
Diphenhydramine Hydrochloride
|
Diphendrasaph
|
25 mg
|
Capsule
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
09 May 2023
|
09 May 2028
|
| View |
|
DRP-13845
|
Metformin Hydrochloride
|
Metokon
|
500 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial (Re-application)
|
28 April 2023
|
28 April 2028
|
| View |
DR-XY47704_PI_01.pdf
|
DR-XY47704
|
Ibrutinib
|
Imbruvica
|
140 mg
|
Capsule
|
-
|
Cilag AG
|
Switzerland
|
Monitored Release (Variation)
|
09 May 2023
|
09 May 2028
|
| View |
|
DRP-13811
|
Cetrorelix (as acetate)
|
LHix
|
250 mcg
|
Lyophilized Powder for Injection (S.C.)
|
-
|
Gufic Biosciences Limited
|
India
|
Initial
|
04 May 2023
|
04 May 2028
|
| View |
|
HRP-601
|
Chlorhexidine Gluconate
|
None
|
40 mg/mL (4 % w/v)
|
Solution
|
-
|
Philmed Laboratories, Inc.
|
Philippines
|
Initial
|
03 May 2023
|
03 May 2028
|
| View |
|
DRP-13875
|
Ascorbic Acid + Zinc
|
AccessZinc
|
500 mg (equivalent to 562.43 mg Ascorbate)/10 mg
|
Capsule
|
-
|
Opal Laboratories (Pvt.) Limited
|
Pakistan
|
Initial [OTC][PCPR]
|
09 May 2023
|
09 May 2028
|
| View |
|
DRP-13874
|
Phenylpropanolamine + Paracetamol
|
Saphdecon
|
500mg/25 mg
|
Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial [OTC] [PCPR]
|
19 May 2023
|
19 May 2028
|
| View |
|
DRP-13870
|
Montelukast (as sodium) + Levocetirizine hydrochloride
|
Levosaphzine-Plus
|
10 mg/5 mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist-Antihistamine Combination
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (Correction)
|
14 February 2024
|
08 May 2028
|
| View |
|
DRHR-2244
|
Methyl Salicylate + Menthol + Camphor
|
Katinko
|
2 g/2 g/2 g per 100 g
|
Ointment Stick (Ginger and
Patchouli Scent)
|
-
|
Greenstone Pharmaceutical, Inc.
|
Philippines
|
Initial
|
28 April 2023
|
28 April 2028
|
| View |
|
DRP-13878
|
Multivitamins+ Iron + L-Lysine
|
None
|
Formulation:
Each mL Contains:
Niacin (Vitamin B3)...........15 mg
Thiamine (as HCI) (Vitamin B1).........2.5 mg
Riboflavin (Vitamin B2)..........2.5 mg
Pyridoxine (Vitamin B6).............600 mcg
Cyanocobalamin (Vitamin B12)..............1.5 mcg
Iron (equivalent to 75 mg ferrous sulfate)...............15 mg
L-Lysine (as HCl)..... .75 mg
|
Syrup (Oral Drops)
(Caramel Flavor)
|
-
|
AD Drugstel Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial [OTC][PCPR]
|
10 May 2023
|
10 May 2028
|
| View |
|
DRP-13869
|
Vildagliptin
|
Vildalion-50
|
50 mg
|
Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
09 May 2023
|
09 May 2028
|
| View |
|
DRP-13852
|
Vancomycin (as hydrochloride)
|
Vancoza-1
|
1 g
|
Powder for Injection (I.V.)
|
-
|
Sanjar Pharma LLP
|
India
|
Initial
|
02 May 2023
|
02 May 2028
|
| View |
|
DRP-13851
|
Vancomycin (as hydrochloride)
|
Vancoza-500
|
500 mg
|
Powder for Injection (I.V.)
|
-
|
Sanjar Pharma LLP
|
India
|
Initial
|
02 May 2023
|
02 May 2028
|
| View |
|
DRP-13711
|
Dopamine Hydrochloride
|
Cateph
|
40 mg/mL (200 mg/5mL)
|
Solution for Injection for I.V. Infusion
|
Adrenergic and Dopaminergic Agent
|
Swiss Parenterals Ltd. (Block-B)
|
India
|
Initial (correction)
|
09 May 2023
|
01 February 2028
|
| View |
|
DRP-13800
|
Co-Amoxiclav
|
Moxinova CV
|
156.25 mg/5 mL
|
Powder for Oral Suspension (Orange
Flavor)
|
Antibacterial (Penicillin + Beta-Lactamase Inhibitor)
|
Yeluri Formulations Pvt Ltd.
|
India
|
Initial (Variation)
|
21 March 2024
|
21 March 2029
|
| View |
|
DRP-2300-01
|
Doxorubicin Hydrochloride
|
None
|
50mg
|
Lyophilized Powder for Injection (IV)
|
Antineoplastic (Anthracycline and related substances)
|
Celon Laboratories Private Limited
|
India
|
Automatic Renewal
|
20 May 2023
|
02 July 2028
|
| View |
|
DRHR-2250
|
Ethyl Alcohol
|
Cristin
|
70% (v/v)
|
Solution
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
12 May 2023
|
12 May 2025
|