| View |
|
DRP-14409
|
Iopamidol
|
None
|
755.22 mg/mL (equivalent to 370 mg Iodine)
|
Solution for Injection for Intravascular Use Only (Not for Intrathecal Use)
|
-
|
Jodas Expoim Pvt. Ltd.
|
India
|
Initial
|
05 September 2023
|
05 September 2028
|
| View |
|
DRP-14408
|
Iopamidol
|
Iopamedix
|
755.22 mg/mL (equivalent to 370 mg Iodine)
|
Solution for Injection for Intravascular Use Only (Not for Intrathecal Use)
|
-
|
Jodas Expoim Pvt. Ltd.
|
India
|
Initial
|
05 September 2023
|
05 September 2028
|
| View |
|
DRP-14411
|
Iopamidol
|
None
|
755.22 mg/mL (equivalent to 370 mg Iodine)
|
Solution for Injection for Intravascular Use Only (Not for Intrathecal Use)
|
-
|
Jodas Expoim Pvt. Ltd.
|
India
|
Initial
|
05 September 2023
|
05 September 2028
|
| View |
|
DRP-14410
|
Iopamidol
|
Iopamedix
|
755.22 mg/mL (equivalent to 370 mg Iodine)
|
Solution for Injection for Intravascular Use Only (Not for Intrathecal Use)
|
-
|
Jodas Expoim Pvt. Ltd.
|
India
|
Initial
|
05 September 2023
|
05 September 2028
|
| View |
|
DRP-14394
|
Telmisartan + Amlodipine (as besilate)
|
TeliDril 80 Pro
|
80 mg/10 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
31 August 2023
|
31 August 2028
|
| View |
|
DRP-14396
|
Telmisartan + Amlodipine (as besilate)
|
None
|
80 mg/10 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
31 August 2023
|
31 August 2028
|
| View |
|
DRP-14392
|
Telmisartan + Amlodipine (as besilate).
|
TeliGen-80 Pro.
|
80 mg/10 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
31 August 2023
|
31 August 2028
|
| View |
|
DRP-14390
|
Telmisartan + Amlodipine (as besilate)
|
TeliSolv Pro
|
80 mg/10 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
31 August 2023
|
31 August 2028
|
| View |
|
DRP-14444
|
42% Glucose + 20% Lipids Emulsion + 10% Amino
Acids with Electrolytes.
|
Omapone Central
|
Solution A (10% Amino Acids with Electrolytes):
Each 100 mL contains:
L-Alanine 1.40 g
L-Arginine 1.20 g
Glycine 1.10 g
L-Histidine 300 mcg
L-Isoleucine 500 mcg
L-Leucine 740 mcg
L-Lysine acetate (as L-Lysine 930 mcg) 660 mcg
L-Methionine 430 mcg
L-Phenylalanine 510 mcg
L-Proline 1.12 g
L-Serine 650 mcg
Glacial acetic acid q.s.
Water for Injection q.s.
Taurine 100 mcg
L-Threonine 440 mcg
L-Tryptophan 200 mcg
L-Tyrosine 40 mcg
L-Valine 620 mcg
Calcium chloride dihydrate (as Calcium as calcium chloride dehydrate 74 mcg) 56 mcg
Sodium glycerophosphate (anhydrous) 418 mg
Magnesium sulfate (as magnesium sulfate hepathydrate 247 mcg) 120 mcg
Potassium chloride 448 mcg
Sodium acetate (as sodium acetate trihydrate 526 mcg) 340 mcg
Zinc (as zinc sulfate heptahydrate 2.3 mcg) 0.5 mcg
Solution B (42% Glucose):
Each 100 mL contains:
Glucose monohydrate (as Glucose 46.2g) 42 g
Hydrochloric acid q.s
Water for injection q.s
Emulsion C (20% Lipids Emulsion)
Each 100 mL contains:
Soybean oil, refined 6 g
Medium-chain triglycerides 6 g
Olive oil, refined 5 g
Fish oil, rich in omega 3 acids 3 g
Egg lecithin 1.2 g
Sodium oleate 30 mcg
dl-a-tocopherol 19.4 mg
Glycerol 2.5 g
Sodium hydroxide q.s.
Water for injection q.s.
|
Emulsion for I.V. Infusion
|
Parenteral Nutrition
|
Hk Inno.N Corporation.
|
Korea
|
Initial (Re-application)
|
05 September 2023
|
05 September 2028
|
| View |
|
DRP-14445
|
20% Lipids Emulsion + 13% Glucose + 10% Amino
Acids with Electrolytes
|
Omapone Peri
|
(see attached Unit Dose Formulation per 100 mL)
|
Emulsion for I.V. Infusion
|
-
|
Hk Inno.N Corporation
|
Korea
|
Initial (Re-application)
|
05 September 2023
|
05 September 2028
|
| View |
|
DRP-14397
|
Telmisartan + Amlodipine (as besilate)
|
None
|
40 mg/5 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
31 August 2023
|
31 August 2028
|
| View |
|
DRP-14395
|
Telmisartan + Amlodipine (as besilate)
|
TeliDril 40 Pro
|
40 mg/5 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
31 August 2023
|
31 August 2028
|
| View |
|
DRP-14393
|
Telmisartan + Amlodipine (as besilate)
|
TeliGen-40 Pro
|
40 mg/5 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
31 August 2023
|
31 August 2028
|
| View |
|
DR-XY48862
|
Telmisartan + Amlodipine (as besilate)
|
Besylon Plus
|
40 mg/5 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
31 August 2023
|
31 August 2028
|
| View |
|
DRP-14391
|
Telmisartan + Amlodipine (as besilate)
|
TeliSolv Pro
|
40 mg/5 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
31 August 2023
|
31 August 2028
|
| View |
|
DR-XY48874
|
Iron Sucrose (as Ferric Hydroxide Sucrose Complex)
|
Porsrose
|
20 mg/mL (100 mg/5 mL)
|
Solution for Injection (IV)
|
-
|
Med Biopharm Pvt. Ltd.
|
India
|
Initial
|
12 September 2023
|
12 September 2028
|
| View |
|
DR-XY48875
|
Ketorolac Tromethamine
|
Ketoropors
|
300 mg/mL
|
Solution for Injection (IM/IV)
|
-
|
Med Biopharm Pvt. Ltd.
|
India
|
Initial
|
04 December 2023
|
12 September 2028
|
| View |
|
DRP-14417
|
Tacrolimus
|
Tecum 0.03%
|
300 mcg/g (0.03% w/w)
|
Ointment
|
-
|
KLM Laboratories Pvt. Ltd.
|
India
|
Initial
|
04 September 2023
|
04 September 2028
|
| View |
|
DRP-14416
|
Tacrolimus
|
Tecum 0.1%
|
1 mg/g (0.1% w/w)
|
Ointment
|
-
|
KLM Laboratories Pvt. Ltd.
|
India
|
Initial
|
04 September 2023
|
04 September 2028
|
| View |
|
DR-XY48877
|
Ledipasvir + Sofosbuvir
|
Ledihep
|
90 mg/400 mg
|
Film-Coated Tablet
|
-
|
Cadila Healthcare Limited
|
India
|
Monitored Release (Re-application)
|
08 September 2023
|
08 September 2026
|