| View |
|
DRP-12849
|
Zoledronic acid (as monohydrate)
|
Pagnel
|
4mg/5mL
|
Powder for Solution for Infusion (I.V.)
|
Bisphosphonate
|
Venus Remedies Limited
|
India
|
Initial
|
14 October 2022
|
14 October 2027
|
| View |
|
DRMO-91
|
Medical Grade Oxygen
|
JEMGAS
|
None
|
None
|
-
|
Jemgas Trading Inc.
|
Philippines
|
Initial
|
13 October 2022
|
13 October 2027
|
| View |
|
DRP-12842
|
Aluminum Hydroxide + Magnesium Hydroxide + Simethicone
|
None
|
200 mg/200 mg/25 mg
|
Chewable Tablet
|
Antacid/ Antiflatulent
|
Phil. United Pharma Corp.
|
Philippines
|
Initial
|
13 October 2022
|
13 October 2027
|
| View |
|
DRP-12841
|
Multivitamins + Minerals
|
Gestacare OB
|
Formulation: Each Tablet contains: Retinyl Acetate (Vitamin A) -3000 IU
Cyanocobalamin (Vitamin B12) -4 mcg
Colecalciferol (Vitamin D3) -400 IU
Niacinamide-30 mg
Thiamine Mononitrate (Vitamin B1)-10 mg
Calcium Pantothenate
Calcium (equivalent to 249,73 of Calcium Carbonate)-100 mg Iron (equivalent to 30.42 mg Ferrous Fumarate)-30 mg Copper (equivalent to 251.17 mcg Copper Sulfate Pentahydrate)-100 mcg Iodine (equivalent to 130.81 mcg of Potassium lodide)-100 mcg
Riboflavin (Vitamin B2) -2.5 mg
Follic Acid -1 mg
1
Pyridoxine Hydrochloride (Vitamin B6) -15 mg
Ascorbic Acid -100 mg
|
Film Coated Tablet
|
Vitamins / Minerals
|
Phil. United Pharma Corp.
|
Philippines
|
Initial (OTC)
|
13 October 2022
|
13 October 2027
|
| View |
|
DR-XY48409
|
Pralsetinib
|
Gavreto
|
100 mg
|
Capsule
|
Antineoplastic Agent
|
Catalent CTS, LLC.
|
United States of America
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12820
|
Fosfomycin (as trometamol)
|
Unifos
|
3 g
|
Granules for Oral Solution
|
-
|
Neutec Ilac San. Tic. A.Ş.
|
Turkey
|
Initial
|
10 October 2022
|
10 October 2027
|
| View |
|
DR-XY48412
|
Ropivacaine Hydrochloride
|
Rocaine
|
10 mg/mL (100 mg/10 mL)
|
Solution for Injection (I.V.)
|
-
|
Biomendi, S.A.
|
Spain
|
DR-XY48412
|
06 March 2023
|
07 October 2027
|
| View |
|
DRP-12797
|
Ceftriaxone (As Sodium)
|
Cefisan
|
1 g
|
Powder for Injection (I.M/I.V.)
|
Antibacterial (Third Generation Cephalosporin)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12828
|
Telmisartan
|
Actarb 40
|
40 mg
|
Tablet
|
Angiotensin II Receptor Blocker
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial (Reconstruction)
|
22 May 2024
|
11 October 2027
|
| View |
|
DRP-12827
|
Telmisartan
|
Actarb 80
|
80 mg
|
Tablet
|
Angiotensin II Receptor Blocker
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial (Reconstruction)
|
22 May 2024
|
11 October 2027
|
| View |
|
DRP-12792
|
Colistimethate Sodium
|
Colitas-2M
|
160 mg
(Equivalent to 2 million International Units)
|
Lyophilized Powder for Injection (IV)
|
Antibacterial (Polymyxin)
|
Gufic Biosciences Limited
|
India
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12851
|
Teicoplanin
|
Planicid
|
400mg
|
Lyophilized Powder for Injection (IM/IV)
|
Antibacterial (Glycopeptide)
|
Centurion İlaç Sanayi ve Ticaret A.Ş. Ankara Şubesi
|
Turkey
|
Initial
|
14 October 2022
|
14 October 2027
|
| View |
|
DRP-12801
|
Omeprazole (as Sodium)
|
Serocid
|
40mg
|
Lyophilized Powder For IV Injection
|
Proton Pump Inhibitor
|
Centurion Ilac Sanayi ve Ticaret A.S. Ankara Subesi
|
Turkey
|
Initial
|
12 October 2022
|
12 October 2027
|
| View |
|
DRP-12807
|
Metformin Hydrochloride
|
Metcore
|
500 mg
|
Film-Coated Tablet
|
Blood Glucose Lowering Drug (Biguanide)
|
Acme Formulation Pvt Ltd.
|
india
|
Initial
|
07 October 2022
|
07 October 2027
|
| View |
|
DRP-12821
|
Losartan potassium + Hydrochlorothiazide
|
Combizar
|
100 mg / 25 mg
|
Film-Coated Tablet
|
Angiotensin II receptor blocker (ARB) and diuretic
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial
|
12 October 2022
|
12 October 2027
|
| View |
|
DRP-12776
|
Telmisartan + Hydrochlorothiazide
|
Merit Plus
|
80 mg/25 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB) and diuretic
|
Krka, d. d., Novo mesto
|
Slovenia
|
Initial
|
11 October 2022
|
11 October 2027
|
| View |
DR-XY48402_PI_01.pdf
|
DR-XY48402
|
Indacaterol (as acetate) + Mometasone furoate
|
Atectura Breezhaler
|
150 mcg/ 80 mcg (equivalent to 125 mcg/ 62.5 mcg
delivered dose)
|
Powder for Inhalation in Hard Capsule
|
-
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
|
DR-XY48403
|
Indacaterol (as acetate) + Mometasone furoate
|
None
|
150 mcg/ 320 mcg (equivalent to 125 mcg/ 260 mcg delivered dose)
|
Powder for Inhalation in Hard Capsule
|
Adrenergic-Corticosteroid Combination
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
|
DR-XY48404
|
Indacaterol (as acetate) + Mometasone furoate
|
None
|
150 mcg/ 160 mcg (equivalent to 125 mcg/ 127.5 mcg delivered dose)
|
Powder for Inhalation in Hard Capsule
|
Adrenergic-Corticosteroid Combination
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
|
DR-XY48405
|
Indacaterol (as acetate) + Mometasone furoate
|
None
|
150 mcg/ 80 mcg (equivalent to 125 mcg/ 62.5 mcg delivered dose)
|
Powder for Inhalation in Hard Capsule
|
Adrenergic-Corticosteroid Combination
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2027
|