View |
|
DRP-15205
|
Enalapril maleate
|
Enaprinova-10
|
10 mg
|
Tablet
|
Angiotensin-converting Enzyme (ACE) Inhibitor
|
S Kant Healthcare Ltd.
|
India
|
Initial
|
24 May 2024
|
24 May 2029
|
View |
|
DRP-15145
|
Carbamazepine
|
None
|
400 mg
|
Extended-Release Tablet
|
Antiepileptic
|
Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Limited)
|
India
|
Initial
|
23 May 2024
|
23 May 2029
|
View |
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DR-XY 49093
|
Ticagrelor
|
Medglor 90
|
90 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Exemed Pharmaceuticals
|
India
|
Initial
|
24 May 2024
|
24 May 2029
|
View |
|
DRP-15190
|
Ceftriaxone (as sodium)
|
Geoxone
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Third-generation Cephalosporin)
|
Swiss Parenterals Ltd.
|
India
|
Initial
|
23 May 2024
|
23 May 2029
|
View |
|
DR-XY49092
|
Tranexamic Acid
|
Khrizemic
|
100 mg/mL (500 mg/5 mL)
|
Solution for Injection (I.V.)
|
Antifibrinolytic
|
Skymap Healthcare Pvt. Ltd.
|
India
|
Initial
|
24 May 2024
|
24 May 2029
|
View |
|
DRP-15202
|
Bupivacaine hydrochloride
|
Blesupican
|
5 mg/mL (0.5% w/v)
|
Solution for Intrathecal Injection Local Anesthetic (Amide)
|
Local Anesthetic (Amide)
|
Makcur Laboratories Limited
|
India
|
Initial
|
24 May 2024
|
24 May 2029
|
View |
|
DRP-15198
|
Duloxetine (as hydrochloride)
|
Dulox 60
|
60 mg
|
Delayed-Release Capsule
|
Antidepressant
|
Hetero Labs Limited (Unit III)
|
India
|
Initial
|
24 May 2024
|
24 May 2029
|
View |
|
DRP-15200
|
Cefazolin (as sodium)
|
Bacefaz
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (First Generation Cephalosporin)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
24 May 2024
|
24 May 2029
|
View |
|
DRP-15199
|
Duloxetine (as hydrochloride)
|
Dulox 30
|
30 mg
|
Delayed Release Capsule
|
Antidepressant
|
Hetero Labs Limited (Unit III)
|
India
|
Initial
|
24 May 2024
|
24 May 2029
|
View |
|
DR-XY49091
|
Ceftriaxone (as sodium)
|
Zeftinox
|
1 g
|
Powder for Solution for Injection (IV/IM)
|
Third-Generation Cephalosporin
|
Chengdu Brilliant Pharmaceutical Co., Ltd.
|
China
|
Initial
|
23 May 2024
|
23 May 2029
|
View |
BR-1473_PI_01.pdf
|
BR-1473
|
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) (Correction)
|
17 September 2024
|
22 May 2029
|
View |
BR-1474_PI_01.pdf
|
BR-1474
|
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) (Correction)
|
17 September 2024
|
22 May 2029
|
View |
BR-1475_PI_01.pdf
|
BR-1475
|
Semaglutide
|
Wegovy
|
1 mg/0.5 mL (2 mg/mL)
|
Solution for Injection (SC)
|
Glucagon-like peptide (GLP-1) Analogues
|
Catalent Belgium
|
Belgium
|
Monitored Release (MR) (Correction)
|
17 September 2024
|
22 May 2029
|
View |
BR-1476_PI_01.pdf
|
BR-1476
|
Semaglutide
|
Wegovy
|
0.5 mg/0.5 mL (1 mg/mL)
|
Solution for Injection (SC)
|
Glucagon-like peptide (GLP-1) Analogues
|
Catalent Belgium
|
Belgium
|
Monitored Release (MR) (Correction)
|
17 September 2024
|
22 May 2029
|
View |
BR-1477_PI_01.pdf
|
BR-1477
|
Semaglutide
|
Wegovy
|
0.25 mg/0.5 mL (0.5 mg/mL)
|
Solution for
Injection (SC)
|
Glucagon-like peptide (GLP-1) Analogues
|
Catalent Belgium
|
Belgium
|
Monitored Release (MR) (Correction)
|
17 September 2024
|
22 May 2029
|
View |
|
DRP-15194
|
Diosmin Hesperidin
|
None
|
900 mg / 100 mg
|
Film-Coated Tablet
|
Vasoprotective
|
Novagen Healthcare Pvt. Ltd.
|
India
|
Initial
|
23 May 2024
|
23 May 2026
|
View |
|
DRP-15191
|
Clopidogrel (as bisulfate)
|
Platclo
|
75 mg
|
Film-Coated Tablet
|
Antithrombotic
|
Medreich Limited (Unit 3)
|
India
|
Initial
|
22 May 2024
|
22 May 2029
|
View |
|
DRP-15192
|
Paracetamol
|
Remol 500
|
500 mg
|
Tablet
|
Analgesic / Antipyretic
|
Rhydburg Pharmaceuticals Limited
|
India
|
Initial
|
23 May 2024
|
23 May 2029
|
View |
|
DRP-15203
|
Rivaroxaban
|
Brelta 15
|
15 mg
|
Film-Coated Tablet
|
Antithrombotic agent (Direct factor Xa inhibitor)
|
Inventia Healthcare Limited
|
India
|
Initial [Re-Application]
|
24 May 2024
|
24 May 2029
|
View |
|
DRHR-2361
|
Methyl Salicylate + Menthol + Eucalyptus Oil +
Camphor/ Menthol + Camphor
|
Katinko Duo Relief
|
Formulation;
Liniment: Each mL contains
Methyl Salicylate 300 mg
Menthol 150 mg
Eucalyptus Oil 100 mg
Camphor 100 mg
Inhaler: Each mL contains Methyl Salicylate 450 mg
Menthol 450 mg
|
Liniment/Inhaler
|
Counterirritant
|
Greenstone Pharmaceutical Inc.
|
Philippines
|
Initial
|
23 May 2024
|
23 May 2029
|