| View |
|
DRP-12406
|
Ascorbic Acid + Zinc
|
Oxizinc
|
500 mg (equivalent to 568.18 mg Sodium Ascorbate) / 10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Vitamin/Mineral
|
Kanion Pharmaceutical Co., Ltd.
|
China
|
Initial (OTC)
|
02 August 2022
|
02 August 2027
|
| View |
|
BR-1407
|
Pertuzumab + Trastuzumab
|
Phesgo
|
1200 mg / 600 mg/ 15 mL
|
Solution For Injection (SC)
|
-
|
F. Hoffmann-La Roche, Ltd.
|
Switzerland
|
Monitored Release
|
29 July 2022
|
29 July 2027
|
| View |
|
BR-1408
|
Pertuzumab + Trastuzumab
|
Phesgo
|
600 mg / 600 mg/ 10mL
|
Solution For Injection (SC)
|
-
|
F. Hoffmann-La Roche, Ltd.
|
Switzerland
|
Monitored Release
|
29 July 2022
|
29 July 2027
|
| View |
|
DRP-12432
|
Ascorbic Acid + Calcium + Colecalciferol (Vitamin D3)
+ Zinc
|
Caldeezee
|
500 mg (equivalent to 605.20 mg Calcium Ascorbate) / 500 mg (equivalent to 105.5 mg Calcium Citrate) / 100 IU / 20 mg (equivalent to 54.9 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Vitamins/Minerals
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
08 August 2022
|
08 August 2027
|
| View |
|
DRP-12431
|
Multivitamins + Minerals
|
Multizin
|
Formulation: Each Film-Coated Tablet contains: Vitamin A (equivalent to 3000 IU Beta-Carotene and 1000 IU Retinyl Acetate)
4000 IU Thiamine Mononitrate (Vitamin B1)
2.18 mg Riboflavin (Vitamin B2)
3.2 mg Nicotinamide (Vitamin B3)
15 mg Pantothenic Acid (Vitamin B5) (as Calcium Pantothenate)
10mg Pyridoxine Hydrochloride (Vitamin B6) Biotin (Vitamin B7)
45 mcg Folic Acid (Vitamin B9)
300 mcg Cyanocobalamin (Vitamin B12) Ascorbic Acid (Vitamin C)
100 mg Vitamin D3
600 IU
75 IU dl-Alpha-Tocopheryl Acetate (Vitamin E) Vitamin K1
12 mcg
Calcium (as Calcium Carbonate and Calcium Hydrogen Phosphate Anhydrous)
200 mg
100 mcg Chromium (as Chloride) Copper (as Sulfate Anhydrous)
500 mcg lodine (as Potassium lodide)
150 mcg Iron (as Ferrous Fumarate)
4 mg Lutein
500 mcg
600 mcg Lycopene Magnesium (as Oxide)
50 mg Magnesium (as Sulfate Monohydrate)
3.5 mg Phosphorus
50 mg Potassium (as Sulfate)
80 mg Selenium (as Sodium Selenate)
55 mcg Zinc (as Oxide)
7.5 mg
8 mg
25 mcg
|
Film-Coated Tablet
|
Vitamins/Minerals
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
08 August 2022
|
08 August 2027
|
| View |
|
DRP-12433
|
Ascorbic Acid + Zinc
|
Immunavit-1020
|
1000 mg (equivalent to 1124.86 mg Sodium Ascorbate) /
20 mg (equivalent to 140 mg Zinc Gluconate)
|
Hard Gelatin Capsule
|
Vitamin / Mineral
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
08 August 2022
|
08 August 2027
|
| View |
|
DR-XY48250
|
Paracetamol
|
Osteomol
|
665 mg
|
Modified Release Tablet
|
Analgesic/ Antipyretic
|
Alkem Laboratories Limited
|
India
|
Monitored Release
|
02 August 2022
|
02 August 2027
|
| View |
|
DR-XY36119
|
Simvastatin
|
Simvoget
|
10 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitor
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
08 August 2022
|
08 August 2027
|
| View |
|
DR-XY48257
|
Alendronic Acid
|
None
|
70 mg/ 100 mL
|
Oral Solution
|
Bisphosphonate
|
Pinewood Laboratories Ltd.
|
Ireland
|
Monitored Release
|
04 August 2022
|
04 August 2027
|
| View |
|
DR-XY48262
|
Ranolazine
|
Razine
|
500 mg
|
Extended-Release Tablet
|
Anti-Anginal
|
Ajanta Pharma Limited
|
India
|
Initial
|
08 August 2022
|
08 August 2027
|
| View |
DR-XY48261_PI_01.pdf
|
DR-XY48261
|
Rosuvastatin (as calcium) + Ezetimibe
|
Zevas
|
10 mg/10 mg
|
Film-Coated Tablet
|
Lipid Modifying Agents
|
Aju Pharm Co., Ltd.
|
Korea
|
Monitored Release
|
05 August 2022
|
05 August 2027
|
| View |
DR-XY48254_PI_01.pdf
|
DR-XY48254
|
Tenofovir alafenamide (as hemifumarate)
|
Tafnext
|
25 mg
|
Film Coated Tablet
|
Antiviral (Nucleoside/Nucleotide Reverse Transcriptase
|
Hetero Labs Limited (Unit-V, Block –VB)
|
India
|
Monitored Release (Correction)
|
27 October 2022
|
03 August 2027
|
| View |
|
DR-XY48232
|
Rosuvastatin (as calcium) + Fenofibrate
|
Rosalfen
|
10 mg/160 mg
|
Film-Coated Tablet
|
Lipid Modifying Agents (HMG COA Reductase Inhibitor/ Fibrate
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
22 August 2022
|
27 July 2027
|
| View |
DR-XY48249_PI_01.pdf
|
DR-XY48249
|
Sildenafil Citrate
|
None
|
50 mg
|
Orally Disintegrating Strip
|
-
|
Zim Laboratories Limited
|
India
|
Monitored Release
|
02 August 2022
|
02 August 2027
|
| View |
|
DR-XY48271
|
Mesalazine
|
Misal
|
1 g
|
Suppository
|
Intestinal Anti-inflammatory Agent
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Monitored Release
|
10 August 2022
|
10 August 2027
|
| View |
DR-XY48256_PI_01.pdf
|
DR-XY48256
|
Colistimethate Sodium
|
None
|
384.61 mg [equivalent to 150 mg Colistin base]
|
Lyophilized Powder for Injection
(I.M./I.V.)
|
Antibacterial
|
Aspiro Pharma Limited SY.
|
India
|
Monitored Release
|
03 August 2022
|
03 August 2025
|
| View |
|
DRP-12386
|
Ketoconazole
|
Ketohab
|
20mg/g (2% w/w)
|
Topical Cream
|
-
|
Dae Hwa Pharmaceutical Co., Ltd.
|
Korea
|
Initial (OTC)(PCPR)
|
29 July 2022
|
29 July 2027
|
| View |
|
DR-XY48270
|
Atorvastatin (as calcium) + Ezetimibe
|
Atorzet 20
|
40 mg / 10 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitor/ Lipid Modifying Agent
|
Medisure Laboratories Pakistan (Pvt.) Ltd.
|
Pakistan
|
Monitored Release
|
10 August 2022
|
10 August 2027
|
| View |
|
DRP-12430
|
Montelukast (as sodium) + Levocetirizine Hydrochloride
|
Moleair
|
10 mg per 5 mg
|
Film Coated Tablet
|
Leukotriene Receptor Antagonist/ Antihistamine
|
Indchemie Health Specialities Pvt. Ltd.
|
India
|
Initial
|
05 August 2022
|
05 August 2027
|
| View |
|
DRP-12425
|
Brompheniramine
|
Bromphenova
|
2mg per 5 mL
|
Syrup
|
Antihistamine
|
T. Man Pharma Company Limited
|
Thailand
|
Initial (OTC)(PCPR)
|
05 August 2022
|
05 August 2027
|