View |
|
DRP-14108
|
dl-alpha Tocopheryl Acetate (Vitamin E).
|
Emina-400
|
400 I.U.
|
Softgel Capsule
|
Vitamin
|
Ocean Healthcare Pvt. Ltd.
|
India
|
Initial
|
22 June 2023
|
22 June 2028
|
View |
|
DRP-13936
|
Co-Amoxiclav
|
None
|
156.25 mg per 5 mL
|
Powder for Oral Suspension
|
-
|
Bilim Ilaç Sanayi ve Ticaret Anonim Şirketi
|
Turkey
|
Initial (Re-application)
|
18 May 2023
|
18 May 2028
|
View |
|
DRP-13886
|
Co-Amoxiclav
|
None
|
312.5 mg per 5 mL
|
Powder For Oral Suspension
|
-
|
Bilim Ilaç Sanayi ve Ticaret Anonim Şirketi
|
Turkey
|
Initial (Reapplication)
|
18 May 2023
|
18 May 2028
|
View |
|
DRP-13908
|
Sitagliptin (as phosphate monohydrate) + Metformin Hydrochloride
|
None
|
50 mg /500 mg
|
Film-Coated Tablet
|
-
|
Bafna Pharmaceuticals Limited
|
India
|
Initial
|
17 May 2023
|
17 May 2028
|
View |
|
DRP-13907
|
Irinotecan Hydrochloride
|
None
|
20 mg/mL (100 mg/5 mL)
|
Concentrate Solution for
Intravenous Infusion
|
-
|
Eugia Pharma Specialities Limited
|
India
|
Initial
|
16 May 2023
|
16 May 2028
|
View |
|
DRP-13918
|
Clarithromycin
|
Clarisaph-250
|
250mg/5mL
|
Granules For Oral Suspension
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
17 May 2023
|
17 May 2028
|
View |
|
DRP-13402
|
Glimepiride
|
Norizec
|
1 mg
|
Tablet
|
-
|
PT Darya-Varia Laboratoria TBK
|
Indonesia
|
Initial (Reconstruction)
|
11 October 2023
|
14 February 2028
|
View |
|
DRP-13403
|
Glimepiride
|
Norizec
|
2 mg
|
Tablet
|
-
|
PT Darya-Varia Laboratoria TBK
|
Indonesia
|
Initial (Reconstruction)
|
11 October 2023
|
14 February 2028
|
View |
|
DRP-13937
|
Losartan Potassium + Hydrochlorothiazide
|
Losakind-H
|
50mg/12.5mg
|
Film-Coated Tablet
|
-
|
Mankind Pharma Limited (Unit II)
|
India
|
Initial
|
18 May 2023
|
18 May 2028
|
View |
|
DRP-13935
|
Cefixime (as trihydrate)
|
None
|
400 mg
|
Capsule
|
-
|
Medico REmedies Limited
|
India
|
Initial
|
18 May 2023
|
18 May 2028
|
View |
|
DRP-13934
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Zopracil
|
2g/250mg
|
Powder For Injection
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
18 May 2023
|
18 May 2028
|
View |
|
DRP-13938
|
Lidocaine Hydrochloride
|
Saphdocaine-2%
|
20mg/mL (2% w/v)
|
Solution For Injection
|
-
|
Althea Pharma Pvt. Ltd.
|
India
|
Initial
|
19 May 2023
|
19 May 2028
|
View |
|
DRP-13923
|
Empagliflozin + Metformin hydrochloride
|
Jardisure Duo
|
12.5 mg/500 mg
|
Film-Coated Tablet
|
Antidiabetic Agent [Sodium-glucose co-transporter (SGLT2) Inhibitor/Biguanide]
|
Medisure Laboratories Pakistan (Pvt.) Ltd.
|
Pakistan
|
Initial [Correction]
|
16 May 2024
|
17 May 2028
|
View |
|
DRP-13921
|
Mupirocin
|
Mupisoft
|
20mg/g (2% w/w/)
|
Ointment
|
-
|
KLM Laboratories Pvt. Ltd.
|
India
|
Initial
|
17 May 2023
|
17 May 2028
|
View |
|
DRP-13932
|
Amlodipine (as besilate) + Valsartan
|
Ambiforge
|
5 mg/160 mg Film-Coated Tablet
|
Film Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
18 May 2023
|
28 May 2028
|
View |
|
DRP-13919
|
Acetylcysteine
|
Flechem
|
600 mg
|
Powder for Oral Solution
|
-
|
Mascot Health Series Pvt. Ltd.
|
India
|
Initial
|
18 May 2023
|
17 May 2028
|
View |
|
DRP-13927
|
Bortezomib
|
Lymphiomib
|
3.5mg
|
Lyophilized Powder For Solution For Injection
|
-
|
Venus Remedies, Limited
|
India
|
Initial
|
18 May 2023
|
18 May 2028
|
View |
|
DRP-13940
|
Pantoprazole (as sodium sesquihydrate)
|
Pantin 40
|
40 mg
|
Lyophilized Powder For I.V. Injection
|
-
|
Aspiro Pharma Limited
|
India
|
Initial
|
19 May 2023
|
19 May 2028
|
View |
|
DRP-13930
|
Citicoline (as sodium)
|
Curtizur
|
250mg/mL (1g/4ml)
|
Solution For Injection (I.M./I.V.)
|
-
|
Makcur Laboratories Limited
|
India
|
Initial
|
18 May 2023
|
18 May 2028
|
View |
|
DRP-13928
|
Gadodiamide
|
Gadimide
|
287mg/mL
|
Solution For I.V. Injection
|
-
|
Jodas Expoim Pvt. Ltd.
|
India
|
Initial
|
18 May 2023
|
18 May 2028
|