| View |
|
DR-XY49207
|
Esomeprazole (as sodium)
|
Porsesomep
|
40 mg
|
Lyophilized Powder for Injection
|
Proton Pump Inhibitor
|
Med Biopharm Pvt. Ltd.
|
India
|
Initial
|
13 September 2024
|
13 September 2029
|
| View |
|
DRP-15803
|
Sevelamer carbonate
|
Sefos
|
800 mg
|
Film-Coated Tablet
|
Phosphate
Binder (Drug for Treatment of
Hyperkalemia/ Hyperphosphatemia)
|
Nucare Labs LLP
|
India
|
Initial
|
13 September 2024
|
13 September 2029
|
| View |
|
DRP-15723
|
Capecitabine
|
CapeGet
|
500 mg
|
Film-Coated Tablet
|
Antineoplastic
|
Beta Drugs Limited
|
India
|
Initial
|
13 September 2024
|
13 September 2029
|
| View |
|
DRP-15724
|
Letrozole
|
LetroGet
|
2.5 mg
|
Film-Coated Tablet
|
Antineoplastic (Aromatase Inhibitor)
|
Beta Drugs Limited.
|
India
|
Initial
|
13 September 2024
|
13 September 2029
|
| View |
|
DRP-15722
|
Temozolomide
|
TemoGet
|
100 mg
|
Capsule
|
Antineoplastic
|
Beta Drugs Limited
|
India
|
Initial
|
13 September 2024
|
13 September 2029
|
| View |
|
DRP-15784
|
Docetaxel (as trihydrate)
|
Doseget-20
|
20 mg/0.5mL
|
Concentrate Solution for IV Infusion
|
Antineoplastic (Taxane)
|
Beta Drugs Limited
|
India
|
Initial
|
13 September 2024
|
13 September 2029
|
| View |
|
DRP-15785
|
Bendamustine (as hydrochloride)
|
Bendaget
|
100 mg
|
Lyophilized Powder for Concentrate Solution for
IV Infusion
|
Antineoplastic Agent
|
Venus Remedies Limited
|
India
|
Initial
|
13 September 2024
|
13 September 2029
|
| View |
|
DRP-15786
|
Docetaxel (as trihydrate)
|
Doseget-80
|
40 mg/mL (80 mg/2 mL)
|
Concentrate Solution for IV Infusion
|
Antineoplastic Agent
|
Beta Drugs Limited
|
India
|
Initial
|
13 September 2024
|
13 September 2029
|
| View |
|
DRP-15789
|
Meropenem (as trihydrate)
|
Afreenem
|
1 g
|
Powder for Injection (IV)
|
Carbapenem
|
Makcur Laboratories Limited
|
India
|
Initial
|
18 September 2024
|
18 September 2029
|
| View |
|
DRP-15787
|
Paracetamol + Orphenadrine Citrate
|
Medgesic
|
450 mg/ 35 mg
|
Tablet
|
Analgesic/Antipyretic/Muscle Relaxant
|
Saga Lifesciences Limited
|
India
|
Initial
|
12 September 2024
|
12 September 2029
|
| View |
|
DR-XY49208
|
Letrozole
|
Lebreta
|
2.5 mg
|
Tablet
|
Antineoplastic (Aromatase Inhibitor)
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
12 September 2024
|
12 September 2029
|
| View |
|
DRP-15767
|
Rosuvastatin (as calcium)
|
Strator
|
20 mg
|
Film-Coated Tablet
|
HMG CoA Reductase Inhibitor
|
Gracure Pharmaceutical Ltd.
|
India
|
Initial
|
12 September 2024
|
12 September 2029
|
| View |
|
DRP-15643
|
Docetaxel
|
None
|
20 mg/mL
|
Concentrate Solution for IV Infusion
|
Antineoplastic Agent
|
Bruck Pharma Private Limited
|
India
|
Initial
|
13 September 2024
|
13 September 2029
|
| View |
|
DRP-15768
|
Co-Amoxiclav
|
Comaclav 457
|
457 mg/5 ml
|
Powder for Oral Suspension.
|
Antibacterial (Penicillin)
|
Baroque Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
12 September 2024
|
12 September 2026
|
| View |
|
DRP-15780
|
Ceftriaxone (as sodium) + Sulbactam (as sodium)
|
Zutatrix
|
1 g/500 mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Third-generation cephalosporin)
|
Innova Captab Limited
|
India
|
Initial
|
13 September 2024
|
13 September 2029
|
| View |
|
DRP-15765
|
Clopidogrel (as bisulfate)
|
Domidon
|
75 mg
|
Film-Coated Tablet
|
Antithrombotic (Platelet Aggregation Inhibitor)
|
BDA Healthcare Pvt. Ltd.
|
India
|
Initial
|
12 September 2024
|
12 September 2029
|
| View |
|
DRP-15764
|
Bortezomib
|
None
|
3.5 mg
|
Lyophilized Powder for Solution for Injection (I.V./S.C)
|
Antineoplastic agent (Proteasome inhibitor)
|
Venus Remedies Limited
|
India
|
Initial
|
12 September 2024
|
12 September 2029
|
| View |
|
DRP-15801
|
Dutasteride + Tamsulosin hydrochloride
|
Lotuflo-D
|
500 mcg/400 mcg
|
Capsule
|
Benign Prostatic Hypertrophy Drug (Alpha- adrenoreceptor antagonist)
|
Laboratorios Leon Farma S.A.
|
Spain
|
Initial
|
13 September 2024
|
13 September 2029
|
| View |
|
DRP-15770
|
Doxorubicin hydrochloride
|
Adrycin
|
2 mg/mL (20 mg/10 mL)
|
Pegylated Liposomal Concentrate Suspension for Injection (I.V. Infusion)
|
Antineoplastic Agent (Anthracycline)
|
Hetero Labs Limited (Unit VI)
|
India
|
Initial
|
12 September 2024
|
12 September 2029
|
| View |
|
DRP-15766
|
Aripiprazole
|
Coplex
|
15 mg
|
Tablet
|
Antipsychotic
|
Consern Pharma Limited
|
India
|
Initial
|
12 September 2024
|
12 September 2029
|