| View |
|
DRP-15522
|
Azithromycin (as dihydrate)
|
Zirocino
|
500 mg
|
Powder for Injection (I.V.)
|
Antibacterial (Macrolide)
|
Sanjar Pharma LLP
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DR-XY49141
|
Lidocaine (as hydrochloride)
|
Lignovell
|
10 mg/dose
|
Spray
|
Local Anaesthetic (Amide)
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DR-XY49140
|
Mecobalamin
|
Kalmeco
|
500 mcg
|
Capsule
|
Vitamin B12 (Cyanocobalamin and analogue)
|
PT. Kalbe Farma Tbk
|
Indonesia
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DR-XY49138
|
Lidocaine Hydrochloride
|
Inocaine
|
20 mg/mL (2% w/v)
|
Solution for Injection (I.M./S.C.)
|
Local Anesthetic (Amide)
|
Pharmaniaga Lifesciences Sdn. Bhd.
|
Malaysia
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DR-XY49136
|
Metformin (as hydrochloride) + Glibenclamide
|
Glucovance
|
500 mg / 5 mg
|
Film-Coated Tablet
|
Blood Glucose Lowering Drug (Biguanide/Sulfonylurea)
|
PT. Merck Tbk
|
Indonesia
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DR-XY49145
|
Metformin Hydrochloride
|
Aartmin 850
|
850 mg
|
Film-Coated Tablet
|
Blood Glucose Lowering Drug (Biguanide)
|
Pinnacle Life Science Private Limited (Subsidiary of
Aarti Drugs Limited)
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DRP-15537
|
Tacrolimus
|
Tazmuz 5
|
5 mg
|
Capsule
|
Calcineurin Inhibitor
|
MMC Healthcare Ltd.
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DR-XY49150
|
Glutathione (as sodium)
|
Tad-2500
|
100 mg/mL (2.5 g/25 mL)
|
Powder for Solution for Injection (IV Infusion)
|
Antidote
|
Biomedica Foscama Group S.P.A.
|
Italy
|
Monitored Release (Reapplication)
|
31 July 2024
|
31 July 2029
|
| View |
|
BR-1486
|
Luspatercept
|
Rojusna
|
25 mg
|
Powder for Solution for Injection (SC)
|
Antianemic Preparations
|
Patheon Italia S.p.A.
|
Italy
|
Monitored Release (MR)
|
30 July 2024
|
30 July 2029
|
| View |
|
BR-1485
|
Luspatercept
|
Rojusna
|
75 mg
|
Powder for Solution for Injection (SC)
|
Antianemic Preparations
|
Patheon Italia S.p.A.
|
Italy
|
Monitored Release (MR)
|
30 July 2024
|
30 July 2029
|
| View |
|
DRP-15538
|
Tacrolimus
|
Tazmuz 1
|
1 mg
|
Capsule
|
Calcineurin Inhibitor
|
MMC Healthcare Ltd.
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
BRP-041-03
|
Enoxaparin Sodium
|
Enoxbicare-40
|
4000 IU Anti-Factor Xa (equivalent to 40 mg) / 0.4 mL
|
Solution For Injection (SC)
|
Antithrombotic agents
|
Brawn Laboratories Ltd.
|
India
|
Initial (Revalidation) (Reconstruction)
|
31 July 2024
|
09 December 2025
|
| View |
|
DR-XY48243
|
Moxifloxacin (as hydrochloride) + Dexamethasone
phosphate (as sodium)
|
Milflox Dm
|
5 mg/1 mg per mL (0.5%/0.1% w/v)
|
Sterile
Ophthalmic Solution
|
Anti-infective-Corticosteroid Combination
|
Sun Pharmaceutical Industries Ltd.
|
India
|
Monitored Release (Reconstruction)
|
31 July 2024
|
10 December 2026
|
| View |
|
DRP-6051-23
|
Ketoanalogues + Essential Amino Acids
|
Amkoket
|
(See Reverse for Unit Dose Formulation)
|
Film-Coated Tablet
|
Renal Nutrition Therapy
|
Stallion Laboratories Pvt. Ltd
|
India
|
CLIDP Conversion
|
04 August 2024
|
13 March 2030
|
| View |
|
DRP-6051-24
|
Ketoanalogues + Essential Amino Acids
|
Ketorels
|
(See Reverse for Unit Dose Formulation)
|
Film-Coated Tablet
|
Renal Nutrition Therapy
|
Stallion Laboratories Pvt. Ltd.
|
India
|
CLIDP Conversion
|
25 July 2024
|
13 March 2030
|
| View |
|
DRP-6174-08
|
CO-AMOXICLAV
|
CLAVOPPEX
|
457 MG PER 5 ML
|
POWDER FOR SUSPENSION
|
ANTIBACTERIAL (PENICILLIN)
|
J.M. TOLMANN LABORATORIES INC
|
Philippines
|
CLIDP Conversion
|
06 August 2024
|
15 December 2029
|
| View |
|
DRP-6269-02
|
Gemcitabine (As hydrochloride)
|
Pyribine
|
1g
|
Powder for Solution for I.V Infusion
|
Antineoplastic
|
Celon Laboratories Private Limited
|
India
|
CLIDP Conversion
|
06 August 2024
|
18 September 2025
|
| View |
|
DRP-6278-09
|
Guaifenesin + Salbutamol (as sulfate)
|
Ventcare
|
100 mg/2 mg
|
Capsule
|
Expectorant / Selective Beta-2 Adrenoreceptor Agonist
|
J.M. Tolmann Laboratories Inc
|
Philippines
|
CLIDP Conversion
|
06 August 2024
|
05 October 2027
|
| View |
|
DRP-6564-03
|
Irinotecan (as hydrochloride)
|
Irebene
|
20 mg/mL (40 mg/2mL and 100 mg/5 mL)
|
Concentrate for Solution for Infusion (IV)
|
Antineoplastic [Topoisomerase 1 (TOP1) inhibitor]
|
Therdose Pharma Pvt. Ltd
|
India
|
CLIDP Conversion
|
04 August 2024
|
18 March 2026
|
| View |
|
DRP-6794-05
|
Ambroxol Hydrochloride
|
Zobrixol®
|
15 mg/5 mL
|
Syrup
|
Mucolytic
|
Lloyd Laboratories, Inc
|
Philippines
|
CLIDP Conversion
|
04 August 2024
|
21 March 2027
|