| View |
|
DRP-12889
|
Valsartan
|
Saphzar
|
160 mg
|
Film-Coated Tablet
|
Angiotensin-II Receptor Blocker (ARB)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
25 October 2022
|
25 October 2027
|
| View |
|
DRP-12890
|
Valsartan
|
Saphzar
|
80 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
25 October 2022
|
25 October 2027
|
| View |
|
DRP-12888
|
Valsartan
|
Saphzar
|
320 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
25 October 2022
|
25 October 2027
|
| View |
|
DRP-12897
|
Irbesaph + Hydrochlorothiazide
|
Irbedrosaph
|
150mg/12.5 mg
|
Film-Coated Tablet
|
Angiotensin-II Receptor Blocker (ARB)/Diuretic
(Thiazide)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
26 October 2022
|
26 October 2027
|
| View |
|
DRP-12895
|
Irbesaph + Hydrochlorothiazide
|
Irbedrosaph
|
300mg/12.5 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
Spain
|
Initial
|
26 October 2022
|
26 October 2027
|
| View |
|
DRP-12896
|
Irbesaph + Hydrochlorothiazide
|
Irbedrosaph
|
300 mg/25 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
26 October 2022
|
26 October 2027
|
| View |
|
DRP-12917
|
Cetirizine Hydrochloride
|
Allerphil
|
10 mg
|
Film-Coated Tablet
|
Antihistamine (Piperazine derivative)
|
Mercury Laboratories Ltd.
|
India
|
Initial (OTC)
|
28 October 2022
|
28 October 2027
|
| View |
|
DRP-12855
|
Cefuroxime (As Axetil)
|
Philcef-DS 125
|
125mg/mL
|
Powder For Oral Suspension
|
-
|
NGB Laboratories Pvt. Ltd.
|
India
|
Initial
|
28 October 2022
|
28 October 2027
|
| View |
|
DRP-12854
|
Cefuroxime (as axetil)
|
Philcef-DS 250
|
250mg/5mL
|
Powder for Oral Suspension
|
Antibacterial (Cephalosporin)
|
NGB Laboratories Pvt. Ltd.
|
India
|
Initial
|
28 October 2022
|
28 October 2027
|
| View |
|
DR-XY48444
|
Rosuvastatin (as calcium)
|
Rosukon-10
|
10 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitor
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
28 October 2022
|
28 October 2027
|
| View |
|
DRP-12905
|
Sitagliptin + Metforinin Hydrochloride
|
Glusimet
|
50mg/1000mg
|
Film-Coated Tablet
|
Combination of Oral Blood Glucose Lowering Drugs
|
Scilife Pharma (Pvt.) Ltd.
|
Pakistan
|
Initial
|
27 October 2022
|
27 October 2027
|
| View |
|
DR-XY48432
|
Irbesartan + Hydrochlorothiazide
|
Malatan Plus
|
150 mg/12.5 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker-Diuretic Combination
|
Genepharm S.A.
|
Greece
|
Initial (Re-application) [Correction]
|
30 January 2023
|
27 October 2027
|
| View |
|
DR-XY48433
|
Irbesartan + Hydrochlorothiazide
|
Malatan Plus
|
300 mg/12,5 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker-Diuretic Combination
|
Genepharm S.A.
|
Greece
|
Initial (Re-application) [Correction]
|
30 January 2023
|
27 October 2027
|
| View |
|
DR-XY48434
|
Irbesartan + Hydrochlorothiazide
|
Malatan Plus
|
300 mg/25 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker-Diuretic Combination
|
Genepharm S.A.
|
Greece
|
Initial (Re-application) [Correction]
|
30 January 2023
|
27 October 2027
|
| View |
|
DR-XY45929 (for DOH Use Only)
|
Lamivudine + Tenofovir disoproxil fumarate
|
None
|
300 mg/ 300 mg
|
Film-Coated Tablet
|
Nucleoside and Nucleotide Reverse Transcriptase
Inhibitor Combination
|
Hetero Labs Limited (Unit III)
|
India
|
Initial (from Monitored Release)
|
26 October 2022
|
06 June 2027
|
| View |
|
DRP-12908
|
Celecoxib
|
Emicox-400
|
400mg
|
Capsule
|
Non-Steroid Antiinflammatory and Antirheumatic Product (Coxib)
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
27 October 2022
|
27 October 2027
|
| View |
BR-1346_PI_01.pdf
|
BR-1346
|
Semaglutide
|
Ozempic
|
0.25 mg/0.19 mL (1.34 mg/mL)
|
Solution for Injection (SC)
|
Glucagon-like peptide (GLP-1) Analogues
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release (Variation)
|
28 October 2022
|
28 October 2027
|
| View |
|
DRP-12906
|
Metoprolol tartrate
|
Loprexo
|
50 mg
|
Film-Coated Tablet
|
Selective Beta Blocking Agent
|
Globela Pharma Private Limited
|
India
|
Initial (Correction)
|
19 April 2023
|
27 October 2027
|
| View |
|
DRP-12907
|
Metoprolol tartrate
|
Loprexo
|
100 mg
|
Film-Coated Tablet
|
Selective Beta Blocking Agent
|
Globela Pharma Private Limited
|
India
|
Initial (correction)
|
19 April 2023
|
27 October 2027
|
| View |
|
DR-XY48440
|
Nicotine
|
2baconil TTS10
|
7 mg/24 hrs. (17.5 mg/ 10 cm2)
|
Transdermal Patch
|
Drug Used in Nicotine Dependence
|
Rusan Pharma Limited
|
India
|
Monitored Release
|
28 October 2022
|
28 October 2027
|