| View |
|
DRP-13204
|
Clopidogrel (As Bisulfate)
|
None
|
75 mg
|
Film-Coated Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
28 December 2022
|
28 December 2027
|
| View |
|
DR-XY48527
|
Amiodarone Hydrochloride
|
Kabidarone
|
50 mg/mL
|
Solution For Injection (IV)
|
-
|
PT. Ethica Industri Farmasi (PT. Ethica)
|
Indonesia
|
Initial
|
14 December 2022
|
14 December 2027
|
| View |
|
DRP-13142
|
Telmisartan + Amlodipine (as besilate)
|
Telmilop
|
80 mg / 5 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB) and Calcium Channel Blocker
|
Titan Laboratories Pvt. Ltd.
|
India
|
Initial
|
07 December 2022
|
07 December 2027
|
| View |
|
DRP-13160
|
Irinotecan (as Hydrochloride Trihydrate)
|
Irixarri-40
|
20 mg/mL (40 mg/2 mL)
|
Concentrate Solution for IV Infusion
|
-
|
Admac Lifesciences
|
India
|
Initial
|
12 December 2022
|
12 December 2027
|
| View |
|
DRP-13199
|
Ciprofloxacin (As Hydrochloride)
|
Kipro-500
|
500 mg
|
Film-Coated Tablet
|
-
|
Akriti Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
27 December 2022
|
27 December 2027
|
| View |
|
DRP-13163
|
Amlodipine (As Besilate)
|
None
|
5mg
|
Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
14 December 2022
|
14 December 2027
|
| View |
|
DRP-13162
|
Amlodipine (As Besilate)
|
None
|
10mg
|
Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
14 December 2022
|
14 December 2027
|
| View |
|
DRP-13155
|
Pregabalin
|
Pregamed 150
|
150 mg
|
Capsule
|
-
|
Titan Laboratories Pvt. Ltd.
|
India
|
Initial
|
12 December 2022
|
12 December 2027
|
| View |
|
DRP-13209
|
Pregabalin
|
Pregamed-75
|
75 mg
|
Capsule
|
-
|
Titan Laboratories Pvt. Ltd.
|
India
|
Initial
|
29 December 2022
|
29 December 2027
|
| View |
|
DRP-13182
|
Betamethasone (As Valerate)
|
Saphmethasone
|
1 mg/g (0.1% w/w)
|
Cream
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
22 December 2022
|
22 December 2027
|
| View |
|
DRP-13181
|
Tobramycin (as sulfate)
|
Tobrasaph
|
3 mg/mL (0.3% w/v)
|
Ophthalmic Solution (Drops)
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
16 December 2022
|
16 December 2027
|
| View |
|
DRP-13208
|
Febuxostat
|
Urixokind-80
|
80mg
|
Film-Coated Tablet
|
-
|
Mankind Pharma Limited (Unit II)
|
India
|
Initial
|
29 December 2022
|
29 December 2027
|
| View |
|
DRP-13138
|
Doxorubicin Hydrochloride
|
Nudoxa PEG
|
2mg/ mL
|
Pegylated Liposomal Concentrate for Solution
for IV Infusion
|
-
|
Cadila Healthcare Limited
|
India
|
Initial
|
06 December 2022
|
06 December 2027
|
| View |
|
DR-XY48549
|
Erlotinib (as hydrochloride
|
Riltared
|
150 mg
|
Film-Coated Tablet
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Initial
|
29 December 2022
|
29 December 2027
|
| View |
|
DR-XY48529
|
Olmesartan Medoxomil + Amlodipine (as Besilate)
|
Alzor CCB
|
40mg/5mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial (Correction)
|
23 January 2023
|
14 December 2025
|
| View |
|
DR-XY48523
|
Olmesartan Medoxomil + Amlodipine (as Besilate)
|
Alzor CCB
|
40mg/10mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial (Correction)
|
23 January 2023
|
07 December 2025
|
| View |
|
DR-XY48526
|
Cefotaxime (as sodium)
|
Eotax-1000
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
Zee Laboratories Limited
|
India
|
Initial
|
14 December 2022
|
14 December 2027
|
| View |
|
DRP-13161
|
Nicardipine Hydrochloride
|
Masopine
|
1mg/mL
|
Solution for IV Infusion
|
-
|
Mason Pharma
|
India
|
Initial
|
12 December 2022
|
12 December 2027
|
| View |
|
DRP-13146
|
Paracetamol
|
Medpara IV
|
10mg/mL (1% w/v)
|
Solution for IV Infusion
|
-
|
Eurolife Healthcare Pvt. Ltd.
|
India
|
Initial
|
07 December 2022
|
07 December 2027
|
| View |
|
DRP-13164
|
Moxifloxacin (As Hydrochloride)
|
Moxisaph
|
5 mg/mL (0.5% w/w)
|
Sterile Ophtahlmic Solution
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
13 December 2022
|
13 December 2027
|