| View |
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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
|
| View |
|
DRP-14970
|
Etoricoxib
|
Coxwel
|
90 mg
|
Film-Coated Tablet
|
Non-steroid Anti-inflammatory and Anti-rheumatic
Product (Coxib)
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
28 February 2024
|
28 February 2029
|
| View |
|
DRP-14968
|
Doxofylline
|
Saphfylline
|
400mg
|
Tablet
|
Bronchodilator
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
28 February 2024
|
28 February 2029
|
| View |
|
DRP-14976
|
Miconazole
|
Rainazole
|
20 mg/g (2% w/w)
|
Cream
|
Antifungal
|
PSA Chemicals and Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
05 March 2024
|
05 March 2029
|
| View |
|
DRP-14974
|
Iron Folic Acid + Pyridoxine hydrochloride (Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
Ramerate
|
60 mg (equivalent to 187.5 mg Ferrous Sulfate)/600
mcg/20 mg/25 mcg
|
Film-Coated Tablet
|
Anti-anemia/Vitamins
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial
|
05 March 2024
|
05 March 2029
|
| View |
|
DRP-14975
|
Zinc
|
Zitriol
|
30mg
|
Capsule
|
Mineral
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Initial
|
05 March 2024
|
05 March 2026
|
| View |
|
DR-XY48855
|
Deferasirox
|
Defrijet 500
|
500 mg
|
Tablet For Oral Suspension
|
Iron chelating agent
|
Sun Pharmaceutical Industries Limited
|
India
|
Monitored Release (Reconstruction)
|
18 April 2024
|
24 August 2028
|
| View |
|
DR-XY48854
|
Irinotecan Hydrochloride Trihydrate
|
Infuirino
|
1.5 mg/mL (270 mg/180 mL), (300 mg/200 mL),
(315 mg/210 mL), (330 mg/220 mL, (360 mg/240 mL)
|
Solution for IV Infusion
|
Antineoplastic [Topoisomerase 1 (TOP 1) inhibitor]
|
Sun Pharmaceutical Industries Limited
|
India
|
Monitored Release (Correction)
|
18 April 2024
|
24 August 2028
|