| View |
|
DR-XY47846
|
Paclitaxel
|
Bravifo
|
6 mg/mL (300mg/50mL)
|
Solution for Injection (IV
Infusion)
|
Antineoplastic Agent (Taxane)
|
MSN Laboratories Private Limited (Formulations Division)
|
India
|
Initial (Correction)
|
13 March 2023
|
29 March 2027
|
| View |
|
DR-XY47845
|
Paclitaxel
|
Bravifo
|
6 mg/mL (100 mg/16.7 mL)
|
Solution for Injection (IV
Infusion)
|
Antineoplastic Agent (Taxane)
|
MSN Laboratories Private Limited (Formulations Division)
|
India
|
Initial (Correction)
|
13 March 2023
|
29 March 2027
|
| View |
|
DR-XY47844
|
Paclitaxel
|
Bravifo
|
6 mg / mL (30 mg / 5 mL)
|
Solution for Infusion
|
Antineoplastic Agent (Taxane)
|
MSN Laboratories Private Limited (Formulations
Division)
|
India
|
Initial
|
29 March 2022
|
29 March 2027
|
| View |
|
DRP-6278-06
|
Guaifenesin + Salbutamol (As Sulfate)
|
GUIACARE CAP
|
100 mg / 2 mg
|
Capsule
|
Selective Beta-2-Adrenoreceptor Agonist/Expectorant
|
J.M. Tolmann Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
11 February 2023
|
05 October 2027
|
| View |
|
DRP-11547
|
Paracetamol
|
Armacetamol
|
10 mg/mL (1 g/100 mL)
|
Solution for Injection (IV Infusion)
|
Antipyretics/Analgesic (anilide)
|
Genuone Sciences Inc.
|
Korea
|
Initial (Reconstruction)
|
05 August 2022
|
30 March 2027
|
| View |
|
DRP-11587
|
Pantoprazole (as Sodium)
|
Reston
|
40mg
|
Powder For Injection (I.V.)
|
Proton Pump Inhibitor
|
Skymap Healthcare Pvt. Ltd.
|
India
|
Initial (Correction)
|
15 September 2022
|
30 March 2027
|
| View |
|
DRP-11552
|
Candesartan Cilexetil
|
Candesaph-16
|
16mg
|
Tablet
|
Angiotensin-II-Receptor Blocker (ARB)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
29 March 2022
|
29 March 2027
|
| View |
|
DRP-11550
|
Dobutamine
|
Dobutasaph
|
12.50mg/mL(250mg/20mL)
|
Solution for Injection (IV Infusion)
|
Cardiac Stimulant (Adrenergic and dopaminergic agent)
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DRP-11589
|
Mupirocin
|
Bactofix
|
20 mg/g (2% w/w)
|
Ointment
|
Antibacterial
|
Maneesh Pharmaceuticals Ltd.
|
India
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DRP-11553
|
Phenytoin Sodium
|
Qurphen
|
50mg/mL
|
Solution for Injection (IM/IV)
|
Antiepileptic (Hydantoin Derivative)
|
Makcur Laboratories Limited
|
India
|
Initial [Correction]
|
22 April 2022
|
29 March 2027
|
| View |
|
DR-XY47838
|
Iron + Folic Acid
|
Ferrola
|
37 mg/ 800 mcg
|
Gastro-Resistant Tablet
|
Antianemic Preparation (Iron Preparation)
|
Lomapharm GmbH
|
Germany
|
Monitored Release
|
29 March 2022
|
29 March 2025
|
| View |
|
DRP-6219-02
|
Cefuroxime (As Axetil)
|
Lorex
|
500 mg
|
Film-Coated Tablet
|
Antibacterials (Cephalosporin)
|
Maxim Pharmaceuticals Pvt. Ltd.
|
India
|
CLIDP
|
30 March 2022
|
22 August 2026
|
| View |
|
BR-1394
|
Trastuzumab
|
Trazimera
|
150 mg
|
Powder For Concentrate For Solution For Infusion (IV)
|
Monoclonal Antibodies [HER2 (Human Edpidermal Growth Factor Receptor 2) Inhibitors)
|
Pfizer Manufacturing Belgium NV
|
Belgium
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
BR-1395
|
Trastuzumab
|
Trazimera
|
440 mg
|
Powder For Concentrate For Solution For Infusion (IV)
|
Monoclonal Antibodies [HER2 (Human Edpidermal Growth Factor Receptor 2) Inhibitors)
|
Pfizer Manufacturing Belgium NV
|
Belgium
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
BR-1392
|
Rabies Vaccine (Inactivated)
|
Bioshoot
|
2.5 IU
|
Powder for Solution for Injection (IM)
|
Vaccines
|
Changchun Zhuoyi Biological Co., Ltd.
|
China
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DRP-11560
|
Tranexamic Acid
|
Trenzamic
|
100 mg/mL (500 mg/ 5 mL)
|
Solution for Intravenous
(I.V.) Injection
|
Antifibrinolytic
|
Makcur Laboratories Limited
|
India
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DRP-11561
|
Telmisartan + Hydrochlorothiazide
|
Temtan-H 80
|
80 mg/ 12.5 mg
|
Tablet
|
Angiotensin II Receptor blocker - Diuretic combination
|
Hiral Labs Limited
|
India
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY47839
|
Zolendronic Acid
|
None
|
4 mg
|
Lyophilized Powder For Injection (I.V Infusion)
|
-
|
Venus Remedies Limited
|
India
|
-
|
29 March 2022
|
29 March 2027
|
| View |
|
DRHR-2130
|
Povidone-Iodine
|
Betadine
|
100 mg/mL (10% w/v)
|
Povidone-Iodine
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
-
|
30 March 2022
|
30 March 2027
|
| View |
|
DRP-3355-05
|
Ambroxol Hydrochloride
|
Phlegmcure
|
30 mg/ 5 mL
|
Syrup
|
-
|
Azarias Pharmaceutical Laboratories Inc,
|
Philippines
|
-
|
30 March 2022
|
01 August 2026
|