| View |
|
HRP-267-05
|
Povidone-Iodine
|
None
|
100 mg/mL (10% w/v)
|
Topical Solution
|
Antiseptic
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
CLIDP Conversion
|
14 February 2024
|
08 February 2028
|
| View |
|
DRP-14924
|
Esomeprazole (as sodium)
|
Emeraz
|
40 mg
|
Lyophilized Powder for I.V. Injection
|
Proton pump inhibitor
|
Lyka Labs Limited
|
India
|
Initial
|
27 February 2024
|
27 February 2029
|
| View |
|
DRP-14930
|
Gliclazide
|
Proglitab MR 60
|
60mg
|
Modified-Release Tablet
|
Blood Glucose Lowering Drug (Sulfonylurea)
|
Inventia Healthcare Limited
|
India
|
Initial
|
27 February 2024
|
27 February 2029
|
| View |
|
DRP-14967
|
Flunarizine (as dihydrochloride)
|
Fluniz
|
5 mg
|
Capsule
|
Antivertigo
|
Ravian Life Science Pvt. Ltd.
|
India
|
Initial
|
27 February 2024
|
27 February 2029
|
| View |
|
DRP-14963
|
Thiamine (Vitamin B1)+ Pyridoxine (Vitamin B6) +
Cyanocobalamin (Vitamin B12)
|
Nervesaph-B
|
100mg/100 mg/5 mg
|
Film-Coated Tablet
|
Vitamin
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial [OTC]
|
26 February 2024
|
26 February 2029
|
| View |
|
DRP-14964
|
Mupirocin
|
Muprixine
|
20 mg/g (2% w/w)
|
Topical Ointment
|
Antibiotic for Topical Use
|
PSA Chemicals & Pharmaceuticals Pvt. Ltd.
|
India
|
Initial [OTC]
|
07 March 2024
|
07 March 2029
|
| View |
|
DRP-5052-19
|
Cefixime (as trihydrate)
|
None
|
100mg/5mL
|
Granules For Suspension
|
Antibacterial (Third Generation Cephalosporin)
|
J.M. Tolmann Laboratories
|
Philippines
|
Initial (Variation)
|
27 February 2024
|
18 August 2027
|
| View |
|
DRP-14959
|
Furosemide
|
Furosam
|
10 mg/mL (20 mg/2mL)
|
Solution for Injection (IM/IV)
|
Diuretic
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
27 February 2024
|
27 February 2029
|
| View |
|
DRP-14960
|
Paracetamol
|
Philamol
|
10 mg/mL (500 mg/50 mL) and (1g/100 mL)
|
Solution. for Injection (IV Infusion)
|
Analgesic/Antipyretic (Anilide)
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
27 February 2024
|
27 February 2029
|
| View |
DR-XY48128_PI_01.pdf
|
DR-XY48128
|
Famciclovir
|
Penvir 750
|
750mg
|
Film Coated Tablet
|
Antiviral (Nucleoside/nucleotide excl. reverse transcriptase inhibitor)
|
Hetero Labs Limited (Unit V)
|
India
|
Monitored Release (MR) (Correction)
|
27 February 2024
|
21 June 2025
|
| View |
|
DR-XY49011
|
Docetaxel (as Trihydrate)
|
Docetaze
|
20mg/mL
|
Concentrated Solution for I. V. Infusion
|
Antineoplastic Agent (Taxane)
|
Shilpa Medicare Limited, Unit-4. Formulations Sez
|
India
|
Initial (Reapplication)
|
28 February 2024
|
28 February 2029
|
| View |
|
DR-XY49012
|
Docetaxel (as Trihydrate)
|
Docetaze
|
20mg/mL (80 mg/ 4mL)
|
Concentrated Solution for I.V.
Infusion
|
Antineoplastic Agent (Taxane)
|
Shilpa Medicare Limited, Unit-4 Formulations Sez
|
India
|
Initial (Reapplication)
|
28 February 2024
|
28 February 2029
|
| View |
|
BR-1478
|
Rituximab
|
Rituxell
|
10 mg/mL
|
Concentrate for Solution for Infusion (IV)
|
Monoclonal Antibodies
|
Joint Stock Company Biocad
|
Russia
|
Initial
|
28 February 2024
|
28 February 2029
|
| View |
|
BR-1479
|
Bevacizumab
|
Bevalast
|
25 mg/mL
|
Concentrate for Solution for Infusion (IV)
|
Monoclonal Antibodies
|
Joint Stock Company Biocad
|
Russia
|
Initial
|
28 February 2024
|
28 February 2029
|
| View |
|
DRP-14969
|
Doxofylline
|
Saphfylline
|
200 mg
|
Tablet
|
Bronchodilator
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
28 February 2024
|
28 February 2029
|
| View |
|
BR-1470
|
Semaglutide
|
Wegovy
|
0.5 mg/0.37 mL (1.34 mg/mL)
|
Solution for
Injection (SC)
|
Glucagon-like peptide (GLP-1) Analogues
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release (MR)
|
28 February 2024
|
28 February 2029
|
| View |
|
BR-1468
|
Semaglutide
|
Wegovy
|
0.25 mg/0.37 mL (0.68 mg/mL)
|
Solution
Injection (SC)
|
Glucagon-like peptide (GLP-1) Analogues
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release (MR)
|
28 February 2024
|
28 February 2029
|
| View |
|
BR-1469
|
Semaglutide
|
Wegovy
|
2.4 mg/ 0.75 mL (3.2 mg/mL)
|
Solution for
Injection (SC)
|
Glucagon-like peptide (GLP-1) Analogues
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release (MR)
|
28 February 2024
|
28 February 2029
|
| View |
|
BR-1471
|
Semaglutide
|
Wegovy
|
1 mg/0.75 mL (1.34 mg/mL)
|
Solution for Injection (SC)
|
Glucagon-like peptide (GLP-1) Analogues.
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release (MR)
|
28 February 2024
|
28 February 2029
|
| View |
|
BR-1472
|
Semaglutide
|
Wegovy
|
1.7 mg/ 0.75 mL (2.27 mg/mL)
|
Solution for Injection (SC)
|
Glucagon-like peptide (GLP-1) Analogues
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release (MR)
|
28 February 2024
|
28 February 2029
|