| View |
|
DRP-10653
|
Pamidronate (as disodium)
|
Pamronate
|
9 mg/mL
|
Concentrate Solution for IV Infusion
|
Bone Modulating Agent
|
Mefar Ilac Sanayii A.S.
|
Turkey
|
Initial
|
03 January 2022
|
03 January 2027
|
| View |
|
DR-XY41842
|
Piperacillin (As Sodium)+ Tazobactam (As Sodium)
|
Pitztar
|
4 g/500 mg
|
Powder for Injection (IV)
|
Antibacterial
|
Inject Care Parenterals Pvt. Ltd
|
India
|
-
|
27 January 2022
|
26 March 2025
|
| View |
|
DRP-11012
|
Losartan Potassium
|
None
|
50 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Mankind Pharma Limited (Unit II)
|
India
|
Initial
|
03 January 2022
|
03 January 2027
|
| View |
|
DR-XY47664
|
Dexmedetomidine (as Hydrochloride)
|
Kabimidine
|
100 mcg/mL (200 mcg/ 2 mL)
|
Sterile Solution for I.V. Injection
|
Hypnotic/ Sedative
|
Gland Pharma Limited
|
India
|
Initial (Reconstruction)
|
31 July 2024
|
11 January 2027
|
| View |
|
DR-XY47679
|
Tadalafil
|
Talafil
|
10 mg
|
Film-Coated Tablet
|
Urological (Drug Used in Erectile Dysfunction)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Monitored Release
|
28 January 2022
|
28 January 2027
|
| View |
|
DR-XY47672
|
Gliclazide
|
Diakon
|
80 mg
|
Tablet
|
Blood Glucose Lowering Drug (Sulfonylurea)
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
25 January 2022
|
25 January 2027
|
| View |
|
DRP-11069
|
Acetylcysteine
|
None
|
100mg
|
Granules For Oral Solution
|
Mucolytic
|
Lifesquare Laboratories, Inc.
|
Philippines
|
Initial
|
21 January 2022
|
21 January 2027
|
| View |
|
DRP-11037
|
Mebendazole
|
Khrizver
|
500mg
|
Chewable Tablet (Orange Flavor)
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
-
|
12 January 2022
|
12 January 2027
|
| View |
|
DR-XY47663
|
Aripiprazole
|
Arpivex 15
|
15 mg
|
Orally Disintegrating Tablet
|
Antipsychotic
|
West Coast Pharmaceutical Works Ltd.
|
India
|
Initial
|
13 January 2022
|
13 January 2027
|
| View |
|
DR-XY47670
|
Metronidazole
|
Sydenzole
|
500 mg
|
Tablet
|
Antiprotozoal
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial
|
19 January 2022
|
19 January 2027
|
| View |
DR-XY47671_PI_01.pdf
|
DR-XY47671
|
Metronidazole
|
Flagimax
|
500 mg
|
Tablet
|
Antiprotozoal
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial (Correction)
|
19 January 2023
|
19 January 2027
|
| View |
|
DRP-11043
|
Acetylcysteine
|
None
|
100mg/5mL
|
Syrup (Strawberry-Banana Flavor)
|
Mucolytic
|
LifeSquare Laboratories, Inc.
|
Philippines
|
Initial
|
18 January 2022
|
18 January 2027
|
| View |
|
DRP-10990
|
Ursodeoxycholic Acid
|
Bilecid
|
250 mg
|
Capsule
|
Bile and Liver Therapy
|
Akciju Sabiedrība "Grindeks” (Site I)
|
Latvia
|
Initial
|
19 January 2022
|
19 January 2027
|
| View |
|
DRP-11016
|
Timolol (as maleate)
|
Timolet OD
|
5 mg/mL (0.5% w/v)
|
Sterile Ophthalmic Solution
|
Antiglaucoma Preparation and Miotic
|
Sun Pharmaceutical Medicare Limited
|
India
|
Initial (Correction)
|
26 September 2024
|
03 January 2027
|
| View |
|
DRP-11034
|
Cefuroxime (As Axetil)
|
Cephatic-500
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
Theon Pharmaceuticals Limited
|
India
|
Initial
|
27 January 2022
|
27 January 2027
|
| View |
|
DR-XY47668
|
Diclofenac Sodium
|
Voren
|
12.5 mg
|
Rectal Suppository
|
Non-Steroidal Anti-Inflammatory (Acetic Acid Derivative)
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
18 January 2022
|
18 January 2027
|
| View |
|
DR-XY47667
|
Diclofenac Sodium
|
Voren
|
50 mg
|
Rectal Suppository
|
-
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
-
|
18 January 2022
|
18 January 2027
|
| View |
|
DR-XY47669
|
Diclofenac Sodium
|
Voren
|
25 mg
|
Rectal Suppository
|
-
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
-
|
18 January 2022
|
18 January 2027
|
| View |
|
DRP-11073
|
Rosuvastatin (As Calcium)
|
Vasticure-20
|
20 mg
|
Film-Coated Tablet
|
HMG-CoA Reductase Inhibitor
|
Gracure Pharmaceutical Ltd.
|
India
|
Initial
|
25 January 2022
|
25 January 2027
|
| View |
|
DRP-11075
|
Rosuvastatin (As Calcium)
|
Vasticure-10
|
10 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitor
|
Gracure Pharmaceutical Ltd.
|
India
|
Initial
|
25 January 2022
|
25 January 2027
|