| View |
|
DRP-12966
|
Pregabalin
|
Neurobal-150
|
150 mg
|
Capsule
|
Antiepileptic
|
The Madras Pharmaceuticals
|
India
|
Initial
|
10 November 2022
|
10 November 2027
|
| View |
|
BR-1431
|
Faricimab
|
Vabysmo
|
6 mg/0.05 mL (120 mg/mL)
|
Solution For Intravitreal Injection
|
-
|
F. Hoffman-La Roche AG
|
Switzerland
|
Monitored Release
|
14 November 2022
|
14 November 2027
|
| View |
|
DRP-12988
|
Fingolimod (as hydrochloride)
|
Finzant
|
500 mcg
|
Capsule
|
-
|
Aizant Drug Research Solutions Pvt. Ltd.
|
India
|
initial (Reapplication)
|
14 November 2022
|
14 November 2027
|
| View |
|
DRP-12976
|
Budesonide
|
Bruxacort
|
250mcg/mL
|
Suspension For Nebulization
|
-
|
Ha Noi CPC1 Pharmaceutical Joint Stock Company
|
Vietnam
|
Initial
|
18 November 2022
|
18 November 2027
|
| View |
|
DRP-13021
|
Salbutamol (as Sulfate)
|
Ventacort
|
100 mcg/actuation
|
Metered Dose Aerosol Inhaler
|
-
|
World Medicine İlaç Sanayi Ve Ticaret A.Ş.
|
Turkey
|
Initial (correction)
|
23 January 2023
|
17 November 2027
|
| View |
|
FDA-0587936
|
Amoxicillin (as Trihydrate) (Vet.)
|
Farmaxillin 50
|
50 g per 100 g
|
Powder for Oral Solution
|
-
|
Farmabase Saude Animal Ltda.
|
Brazil
|
Initial (Vet.)
|
11 November 2022
|
11 November 2027
|
| View |
|
DRP-13037
|
Ascorbic Acid
|
Cool Fresh
|
1 g per 7 g
|
Powder for Oral Solution (Lime flavor)
|
Vitamin
|
PT Karunia Alam Segar
|
Indonesia
|
Initial
|
21 November 2022
|
21 November 2027
|
| View |
|
DRP-12993
|
Silver Sulfadiazine
|
Suldaxi
|
10 mg/g (1% w/w)
|
Topical Cream
|
-
|
S Kant Healthcare Limited
|
India
|
Initial
|
15 November 2022
|
15 November 2027
|
| View |
|
DRP-13038
|
Ascorbic Acid + Cholecalciferol + Zinc
|
Cidrenzin
|
Formulation:
Each capsule contains:
Ascorbic Acid............100 mg
Ascorbic Acid... ......400 mg
(equivalent to 450 mg Sodium Ascorbate)
Vitamin D3........400 IU .
Zinc... 3.64 mg
(equivalent to 10 mg Zinc Sulfate Monohydrate)
|
Chewable Tablet (Orange Flavor)
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial (OTC)
|
12 November 2022
|
21 November 2027
|
| View |
|
DRP-13036
|
Carbocisteine + Zinc
|
Saphcizinc
|
500 mg/5 mg
|
Film Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
21 November 2022
|
21 November 2027
|
| View |
DR-XY48465_PI_01.pdf
|
DR-XY48465
|
Rosuvastatin (as calcium) + Ezetimibe
|
Zenon
|
10 mg/ 10 mg
|
Film-Coated Tablet
|
-
|
Sanofi Ilac Sanayi Ve Ticaret Anonim Sirketi
|
Turkey
|
Monitored Release (Re-application)
|
14 November 2022
|
14 November 2027
|
| View |
DR-XY48466_PI_01.pdf
|
DR-XY48466
|
Rosuvastatin (as calcium) + Ezetimibe
|
Zenon
|
20 mg/ 10 mg
|
Film-Coated Tablet
|
-
|
Sanofi Ilac Sanayi Ve Ticaret Anonim Sirketi
|
Turkey
|
Monitored Release (Re-application)
|
14 November 2022
|
14 November 2027
|
| View |
|
DRP-130118
|
Salbutamol (as sulfate)
|
Asthakler
|
100mcg/dose
|
Inhalational Aerosol
|
-
|
Yangzhou No. 3 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
17 November 2022
|
17 November 2027
|
| View |
BR-1432_PI_01.pdf
|
BR-1432
|
Bacillus Clausii
|
Erceflora
|
4 billion / 5 mL
|
Oral Suspension
|
-
|
Opella Healthcare Italy S.r.L
|
Italy
|
Monitored Release (MR) (Re-application)
|
22 November 2022
|
22 November 2027
|
| View |
|
DRP-12948
|
Ampiciilin (As Sodium)
|
Incalin
|
250 mg
|
Powder for Solution for Injection (IM/IV)
|
-
|
Inject Care Parenterals Pvt. Ltd.
|
Italy
|
Initial
|
11 November 2022
|
11 November 2027
|
| View |
|
DRP-12949
|
Ampiciilin (As Sodium)
|
Incalin
|
500 mg
|
Powder For Solution For Injection (IM/IV)
|
-
|
Inject Care Parenterals Pvt. Ltd.
|
India
|
Initial
|
11 November 2022
|
11 November 2027
|
| View |
|
DRP-13009
|
Irbesartan
|
Irtazep
|
300 mg
|
Tablet
|
-
|
Cooper Pharma Limited
|
Thailand
|
Initial
|
17 November 2022
|
17 November 2027
|
| View |
|
DRP-13010
|
Irbesartan
|
Irtazep
|
150 mg
|
Tablet
|
-
|
Cooper Pharma Limited
|
India
|
Initial
|
17 November 2022
|
17 November 2027
|
| View |
|
DR-XY48459
|
Norepinephrine (as Bitartrate)
|
Fresenor
|
1mg/mL
|
Concentrate Solution for IV Infusion.
|
-
|
PT. Ethica Industri Farmasi (PT.Ethica)
|
Indonesia
|
Initial
|
11 November 2022
|
11 November 2027
|
| View |
|
DRP-13000
|
Sodium Bicarbonate
|
Napracid
|
650 mg
|
Tablet
|
-
|
Drugmaker's Laboratories Inc.
|
Philippines
|
Initial [OTC]
|
16 November 2022
|
16 November 2027
|