| View |
|
DRP-14997
|
Irinotecan Hydrochloride Trihydrate
|
Fin-Otecan
|
20 mg/mL (100 mg/5 mL)
|
Concentrate Solution for IV Infusion
|
Antineoplastic
|
Venus Remedies, Limited
|
India
|
Initial
|
06 March 2024
|
06 March 2029
|
| View |
|
DRP-15007
|
Bupivacaine hydrochloride
|
Spentocaine Heavy
|
5 mg/mL (0.5% w/v)
|
Solution for Intrathecal Injection
|
Local Anesthetic (Amide)
|
Steril-Gene Life Sciences (P) Limited
|
India
|
Initial
|
08 March 2024
|
08 March 2029
|
| View |
|
DRP-15001
|
Sunitinib (as malate)
|
Alsuni
|
12.5 mg
|
Capsule
|
Antineoplastic Agent
|
Lotus Pharmaceutical Co., Ltd. (Nantou Plant)
|
Taiwan
|
Initial
|
07 March 2024
|
07 March 2029
|
| View |
|
DRP-15000
|
Sunitinib (as malate)
|
Alsuni
|
50 mg
|
Capsule
|
Antineoplastic Agent
|
Lotus Pharmaceutical Co., Ltd. (Nantou Plant)
|
Taiwan
|
Initial
|
07 March 2024
|
07 March 2029
|
| View |
|
DRP-14998
|
Amiodarone hydrochloride
|
Miorad
|
50 mg/mL (150 mg/3 mL)
|
Concentrate Solution for Injection (IV)
|
Anti-arrhythmic
|
Swiss Parenterals Ltd. (Block-B)
|
India
|
Initial
|
07 March 2024
|
07 March 2029
|
| View |
|
DR-XY 49015
|
Bupivacaine hydrochloride
|
Bucain Spinal Heavy
|
5 mg/mL (0.5% w/v)
|
Solution for Intrathecal Injection
|
Local Anesthetic (Amide)
|
PT. Bernofarm
|
Indonesia
|
Initial
|
05 March 2024
|
08 March 2029
|
| View |
|
DRP-15005
|
Bupivacaine hydrochloride
|
Spinlok
|
5 mg/mL (0.5% w/v)
|
Solution for Intrathecal Injection
|
Local Anesthetic (Amide)
|
Shree Anand Life Sciences, Ltd.
|
India
|
Initial
|
08 March 2024
|
08 March 2029
|
| View |
|
DR-XY 49016
|
Bupivacaine hydrochloride
|
Porsvacaine
|
5 mg/mL (0.5% w/v)
|
Solution for Injection (Epidural, Intraarticular, Subcutaneous or Perineural)
|
Local Anesthetic (Amide)
|
Med Biopharm Pvt. Ltd.
|
India
|
Initial
|
08 March 2024
|
08 March 2029
|
| View |
|
DRP-14972
|
Prasugrel (as Hydrochloride)
|
Prasu
|
10 mg
|
Film-Coated Tablet
|
Antithrombotic
|
Towa Pharma Private Limited
|
India
|
Initial
|
06 March 2024
|
06 March 2029
|
| View |
|
DRP-15003
|
Mesna
|
Melnna
|
100 mg/mL (400 mg/ 4 mL)
|
Solution for Injection
|
Detoxifying Agent for Antineoplastic Treatment
|
Getwell Pharmaceuticals
|
India
|
Initial
|
07 March 2024
|
07 March 2029
|
| View |
|
DRP-15002
|
Mesna
|
Melnna
|
100 mg/mL (200 mg/ 2 mL)
|
Solution for Injection
|
Detoxifying Agent for Antineoplastic Treatment
|
Getwell Pharmaceuticals
|
India
|
Initial
|
07 March 2024
|
07 March 2029
|
| View |
|
BR-088
|
Enoxaparin Sodium
|
Hepaclex
|
60 mg/0.6 mL
|
Solution for Injection (SC)
|
Antithrombotic Agents
|
Gland Pharma Limited
|
India
|
Renewal
|
07 March 2024
|
04 June 2028
|
| View |
|
DRP-15004
|
Meropenem (as trihydrate)
|
Emapen
|
1 g
|
Powder for Solution for Injection (I.V.)
|
Carbapenem
|
Maxitech Pharma (Pvt) Ltd.
|
Pakistan
|
Initial
|
07 March 2024
|
07 March 2029
|
| View |
|
DRP-14808
|
Levocarnitine
|
Levocarnil
|
200 mg/mL (1 g/5 mL)
|
Solution for Injection (IV)
|
Amino acids and derivatives
|
Farbe Firma Pvt. Ltd.
|
India
|
Initial
|
06 March 2024
|
06 March 2029
|
| View |
|
DR-XY47437
|
Co-Amoxiclav
|
None
|
156.25mg/5 mL
|
Powder for suspension
|
Antibacterial (Penicillin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (Correction)
|
06 March 2024
|
30 September 2026
|
| View |
|
DR-XY48999
|
Valganciclovir (as hydrochloride)
|
VagaCyte
|
450 mg
|
Film-Coated Tablet
|
Antiviral
|
Panacea Biotec Ltd.
|
India
|
Initial
|
11 March 2024
|
11 March 2029
|
| View |
|
DR-XY49018
|
Ascorbic Acid + dl-Alpha Tocopheryl Acetate pha Tocopheryl Acetate (Vitamin E)
|
None
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate) / 12 mg
|
Capsule
|
Vitamins
|
Aldrtz Corporation
|
Philippines
|
Initial
|
12 March 2024
|
12 March 2026
|
| View |
|
DRP-15008
|
Paracetamol + Guaifenesin Phenylephrine.
hydrochloride + Dextromethorphan hydrobromide + Chlorpheniramine maleate
|
None
|
250 mg/100 mg/10 mg/10 mg/1 mg
|
Tablet
|
Antipyretic/Analgesic/Expectorant/Nasal
Decongestant/Antitussive/Antihistamine
|
La Croesus Pharma, Inc.
|
Philippines
|
Initial
|
11 March 2024
|
11 March 2029
|
| View |
|
DRHR-2350
|
Methyl Salicylate + Camphor + Menthol
|
Katinko Calming
|
10 mg / 5 mg per mL
|
Liniment (Lavender Scent)
|
Counterirritant
|
Greenstone Pharmaceutical, Inc.
|
Philippines
|
Initial
|
12 March 2024
|
12 March 2029
|
| View |
|
DRP-15010
|
Ascorbic Acid + Zinc
|
None
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate) / 10 mg (equivalent to 31.11 mg Zinc Citrate)
|
Capsule
|
Vitamin / Mineral
|
Pascual Laboratories, Inc.
|
Philippines
|
Initial
|
12 March 2024
|
12 March 2026
|