| View |
|
DRP-11635-03
|
Amlodipine (as besilate)
|
Xentravasc 5
|
5 mg
|
Tablet
|
Calcium Channel Blocker
|
Ratnatris Pharmaceutical Pvt. Ltd.
|
India
|
CLIDP Conversion
|
10 June 2024
|
04 April 2027
|
| View |
|
DRP-11635-01
|
Amlodipine (as besilate)
|
Genvasc-5
|
5mg
|
Tablet
|
Calcium Channel Blocker
|
Ratnatris Pharmaceutical Pvt. Ltd.
|
India
|
CLIDP Conversion
|
15 June 2024
|
04 April 2027
|
| View |
|
DRP-11057-04
|
Clopidogrel
|
Nuclot
|
75 mg
|
Film-Coated Tablet
|
Platelet Aggregation Inhibitor
|
Centurion Laboratories Pvt. Ltd.
|
India
|
CLIDP Conversion
|
25 July 2023
|
20 January 2027
|
| View |
|
HRP-290-02
|
Povidone-Iodine
|
Iovidone
|
50 mg/g (5% w/w)
|
Cream
|
Antiseptic/Disinfectant
|
ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.
|
China
|
Renewal
|
29 December 2023
|
05 November 2028
|
| View |
|
HRP-288-02
|
Benzoic Acid + Salicylic Acid
|
SALIZOIC
|
120 mg/60 mg per gram (12%/ 6% w/w)
|
Topical Ointment
|
Antifungal/Keratolytic
|
ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD
|
China
|
Renewal
|
31 January 2024
|
05 November 2028
|
| View |
|
DRP-9173-1
|
Bortezomib
|
Delexomib
|
3.5 mg
|
Lyophilized Powder for Injection (S.C./I.V.)
|
Antineoplastic Agent (Proteasome Inhibitor)
|
Venus Remedies Ltd
|
India
|
CLIDP Conversion
|
19 May 2023
|
25 September 2025
|
| View |
|
DRP-13199-1
|
Ciprofloxacin (as hydrochloride)
|
Roflexin
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Fluoroquinolone)
|
Akriti Pharmaceuticals Pvt. Ltd.
|
India
|
CLIDP Conversion
|
28 May 2023
|
27 December 2027
|
| View |
|
DRP-9399
|
Piperacillin (As Sodium) + Tazobactam (As Sodium)
|
IZTAM-4.5
|
4.5 g
|
Powder For Injection For I.V. Infusion
|
Antibacterial (Penicillin)
|
PENMIX LTD.
|
Korea
|
Automatic Renewal
|
03 December 2023
|
29 March 2029
|
| View |
|
FDA-5000004431166
|
Multivitamins + Buclizine Hydrochloride + Lysine Hydrochloride + Ferrous Sulfate
|
Appetite W/ Iron Syrup
|
Thiamine HCl 15mg, Riboflavin (as Sodium Phosphate) 1mg, Nicotinamide 20mg, Pyridoxine HCl 5mg, Cyanocobalamin 5mcg, Iron (as Ferrous Sulfate Heptahydrate) 15mg, Buclizine HCl 5mg, Lysine HCl 100mg per 5mL
|
Syrup
|
APPETITE STIMULANT ,B-COMPLEX VITAMINS AND ANTI-ANEMIC
|
La Croesus Pharma, Inc.
|
Philippines
|
Automatic Renewal
|
24 October 2022
|
19 December 2027
|
| View |
|
DRP-15288
|
Vildagliptin
|
Sunvilda
|
50 mg
|
Tablet
|
Blood glucose lowering drug
(Dipeptidyl peptidase 4 (DPP-4) inhibitor)
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
11 June 2024
|
11 June 2029
|
| View |
|
DRP-15296
|
Esomeprazole (as sodium)
|
Esoriv-40
|
40 mg
|
Lyophilized Powder for Injection (IV)
|
Proton Pump Inhibitor
|
East African (India) Overseas
|
India
|
Initial
|
11 June 2024
|
11 June 2029
|
| View |
|
DRP-15293
|
Linagliptin
|
Tragliptin
|
5 mg
|
Film-Coated Tablet
|
Blood glucose lowering drug
|
Sinil Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
11 June 2024
|
11 June 2029
|
| View |
|
DRP-15308
|
Rosuvastatin (as calcium)
|
Rovecol
|
20 mg
|
Film Coated Tablet
|
Lipid Modifying Agent (HMG CoA reductase inhibitor)
|
Healer's Lab (Unit II)
|
India
|
Initial
|
13 June 2024
|
13 June 2029
|
| View |
|
HRP-653
|
Oral Rehydration Salts
|
APLINC-ORS
|
FORMULATION
Each sachet (4.1 g) contains:
Glucose Anhydrous
2.70 g
Trisodium Citrate Dihydrate 580 mg
Sodium Chloride
520 mg
Potassium Chloride
300 mg
|
Granules for Oral Solution
|
Electrolytes with Carbohydrates
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial
|
13 June 2024
|
13 June 2029
|
| View |
|
HRP-652
|
Oral Rehydration Salts
|
APLINC-ORS
|
FORMULATION
Each sachet (4.1 g) contains:
Glucose Anhydrous
2.70 g
Trisodium Citrate Dihydrate
580 mg
Sodium Chloride
520 mg
Potassium Chloride
300 mg
|
Granules for Oral Solution
(Lychee Flavor)
|
Electrolytes with Carbohydrates
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
13 June 2024
|
13 June 2029
|
| View |
|
DRP-15304
|
Cetirizine hydrochloride
|
None
|
5 mg/5 mL
|
Oral Solution
|
Antihistamine (Piperazine Derivative)
|
Rhydburg Pharmaceuticals Limited.
|
India
|
Initial
|
13 June 2024
|
13 June 2029
|
| View |
|
DRP-15306
|
Iron Folic Acid (Vitamin B9)
|
Fefolife
|
190 mg/400 mcg
|
Film-coated Tablet
|
Mineral/Vitamin
|
Flourish Pharma
|
India
|
Initial
|
13 June 2024
|
13 June 2029
|
| View |
|
DRP-15307
|
Loratadine + Phenylephrine
|
Lophenil
|
5 mg/5 mg per 5 mL
|
Syrup (Raspberry Flavor)
|
Vitamin
|
Azine Healthcare Pvt., Ltd
|
India
|
Initial
|
13 June 2024
|
13 June 2029
|
| View |
|
DRP-15303
|
Phenylephrine hydrochloride + Chlorpheniamine maleate
|
Saphenamine.
|
5 mg/1 mL per 5 mL
|
Syrup
|
Decongestant / Antihistamine.
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
13 June 2024
|
13 June 2029
|
| View |
|
DRP-15302
|
Paracetamol + Phenylephrine hydrochloride
|
Biosaphen
|
500 mg 10 mg
|
Tablet
|
Analgesic Antipyretic / Nasal Decongestant
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
13 June 2024
|
13 June 2029
|