| View |
|
DRP-13069
|
Atorvastatin (as Calcium)
|
None
|
20 mg
|
Film-Coated Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
|
DRP-13059
|
Telmisartan + Amlodipine (as besilate)
|
Telmilop
|
40 mg/ 5 mg
|
Tablet
|
-
|
Titan Laboratories Pvt. Ltd.
|
India
|
Initial (Correction)
|
09 February 2023
|
24 November 2027
|
| View |
|
DRP-13089
|
Telmisartan + Amlodipine (as besilate)
|
Telmilop
|
80 mg / 10 mg
|
Tablet
|
-
|
Titan Laboratories Pvt. Ltd.
|
India
|
Initial
|
28 November 2022
|
28 November 2027
|
| View |
|
DRP-13067
|
Amlodipine (as Besilate)
|
Amlog
|
5mg
|
Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
|
DRP-13068
|
Amlodipine (as Besilate)
|
Amlog
|
10mg
|
Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
|
DR-XY48480
|
Pregabalin
|
Nervica 150
|
150 mg
|
Capsule
|
-
|
Unison Laboratories Co. Ltd.
|
Thailand
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
|
DRP-13035
|
Fluoxetine
|
Oxestal-20
|
20 mg
|
Capsule
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
DRP-13048_PI_01.pdf
|
DRP-13048
|
Salbutamol (as Sulfate) + Ipratropium Bromide
|
Brevoneb
|
2.5 mg / 500 mcg per 2.5 mL
|
Solution For Inhalation
|
-
|
Ahlcon Parenterals (India) Limited
|
India
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
DRP_13055_PI_01.pdf
|
DRP-13055
|
Aceclofenac + Paracetamol
|
ACF-Plus
|
100 mg/ 500 mg
|
Film-Coated Tablet
|
-
|
Mediwin Pharmaceuticals
|
India
|
Initial (from Monitored Release)
|
24 November 2022
|
05 June 2025
|
| View |
|
DRP-13082
|
Glutathione
|
Glutixant
|
600 mg
|
Lyophilized Powder for Injection (I.M./I.V.)
|
-
|
Reyoung Pharmaceutical Co. Ltd.
|
India
|
Initial
|
25 November 2022
|
25 November 2027
|
| View |
DR-XY48483_PI_01.pdf
|
DR-XY48483
|
Indacaterol (as Acetate) + Glycopyrronium (as Bromide) + Mometasone Furoate
|
Enerzair Breezhaler
|
150 mcg/50mcg/160mcg
|
Powder For Inhalation In Hard Capsule
|
-
|
Novartis Pharma Stein AG
|
Malaysia
|
Monitored Release
|
22 November 2022
|
22 November 2025
|
| View |
|
DRP-13072
|
Epirubicin Hydrochloride
|
Episaphcin-10
|
10 mg
|
Lyophilized Powder for Injection (IV)
|
Antineoplastic
|
Bruck Pharma Private Limited
|
Lithuania
|
Initial
|
25 November 2022
|
25 November 2027
|
| View |
|
DRP-13074
|
Gemcitabine (As Hydrochloride)
|
Gemcisaph-1000
|
1 g
|
Lyophilized Powder for Injection (IV Infusion)
|
Antineoplastic
|
Bruck Pharma Private Limited
|
India
|
Initial
|
28 November 2022
|
28 November 2027
|
| View |
|
DRP-13075
|
Gemcitabine (As Hydrochloride)
|
Gemcisaph-200
|
200 mg
|
Lyophilized Powder for Injection (IV Infusion)
|
Antineoplastic
|
Bruck Pharma Private Limited
|
India
|
Initial
|
28 November 2022
|
28 November 2027
|
| View |
|
DRP-13073
|
Epirubicin Hydrochloride
|
Episaphcin-50
|
50 mg
|
Lyophilized Powder For Infusion (IV)
|
-
|
Bruck Pharma Private Limited
|
India
|
Initial
|
25 November 2022
|
25 November 2027
|
| View |
|
DRP-13087
|
Acetylcysteine
|
Mucolus
|
600mg
|
Granules For Oral Solution (Apple Flavor)
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial
|
28 November 2022
|
28 November 2027
|
| View |
|
DRP-13088
|
Acetylcysteine
|
Mucolus
|
600mg
|
Granules For Oral Solution (Orange Flvor)
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial
|
28 November 2022
|
28 November 2027
|
| View |
|
DRP-13063
|
Irinotecan Hydrochloride (as trihydrate)
|
Irixarri-100
|
20mg/mL (100 mg/5 mL)
|
Concentrate Solution For I.V Infusion
|
-
|
ADMAC Lifesciences
|
Indonesia
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
|
DRP-13062
|
Silver Sulfadiazine
|
Silversaph
|
10mg/g (1% w/w)
|
Topical Cream
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
|
DRP-13060
|
Pyrazinamide
|
Pyrazisaph-500
|
500 mg/ 5 mL
|
Oral Suspension
|
-
|
Bueno Salud Care India Pvt. Ltd.
|
India
|
Initial
|
23 November 2022
|
23 November 2027
|