| View |
|
DR-XY47365
|
Erythromycin (as Stearate)
|
Erycol
|
500 mg
|
Film Coated Tablet
|
-
|
Magbro Healthcare Pvt.Ltd.
|
India
|
Initial (Correction)(Re-Issuance)
|
18 August 2022
|
03 September 2026
|
| View |
DR-XY47366_PI_01.pdf
|
DR-XY47366
|
Fluticasone furoate + Umeclidinium (as bromide) +
Vilanterol (as trifenatate)
|
Trelegy Ellipta
|
100 mcg/62.5 mcg/25 mcg
|
Dry Powder For Inhalation
|
-
|
Glaxo Operations UK Ltd.
|
United Kingdom
|
Monitored Release
|
08 September 2021
|
08 September 2024
|
| View |
|
DR-XY47367
|
Prednisolone (as Sodium Phosphate)
|
Liquisone
|
15 mg per 5 mL
|
Oral Solution (Tutti Frutti Flavor)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
08 September 2021
|
08 September 2026
|
| View |
|
DR-XY47368
|
Cholecalciferol
|
Vertid -D3
|
1000IU
|
Capsule
|
Vitamin
|
Nutra Tech Biopharma Inc.
|
Philippines
|
Initial (OTC)
|
07 September 2021
|
07 September 2026
|
| View |
|
DR-XY47369
|
Ascorbic Acid + Zinc
|
Ascozin Max
|
1000 mg / 10 mg (equivalent to 32 mg Zinc Citrate Trihydrate)
|
Effervescent Tablet
|
-
|
Kusum Healthcare Private Limited
|
India
|
Initial (OTC) (Correction)
|
08 September 2021
|
13 July 2026
|
| View |
|
DR-XY47370
|
Ascorbic Acid + Zinc
|
None
|
500 mg (equivalent to 568.18 mg Sodium Ascorbate) 10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
-
|
Northfield Laboratories Inc.
|
Philippines
|
-
|
08 September 2021
|
08 September 2026
|
| View |
|
DR-XY47371
|
Paracetamol
|
Tylenol
|
650 mg
|
Extended Release Tablet
|
-
|
McNeil Consumer Healthcare, Division of Johnson &
Johnson Inc.
|
Canada
|
Initial[OTC]
|
08 September 2021
|
08 September 2026
|
| View |
|
DR-XY47373
|
Levodopa + Carbidopa (as monohydrate)
|
Twindopa
|
250 mg/25 mg
|
Tablet
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial
|
09 September 2021
|
09 September 2026
|
| View |
|
DR-XY47374
|
Ascorbic Acid + Zinc
|
AsconvitaZin
|
533.40 mg (equivalent to 600 mg Sodium Ascorbate)/ 5 mg (equivalent to 13.73 mg Zinc Sulfate)
|
Capsule
|
Vitamin/Mineral
|
Interchemex Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
10 September 2021
|
10 September 2026
|
| View |
|
DR-XY47375
|
Paracetamol + Guaifenesin + Phenylpropanolamine
HC1 + Dextromethorphan HBr + Chlorphenamine Maleate
|
Dynatussin ES
|
500 mg/50 mg/25 mg/15 mg/1 mg
|
Capsule
|
-
|
Hizon Laboratories, Inc.
|
Philippines
|
-
|
10 September 2021
|
10 September 2026
|
| View |
|
DR-XY47376
|
Ascorbic Acid + Zinc
|
Immuntab
|
500 mg (equivalent to 562.42 mg Sodium Ascorbate)/ 10 mg (equivalent to 27.50 mg Zinc Sulfate Monohydrate)
|
Capsule
|
-
|
Am-Europharma Corporation
|
Philippines
|
-
|
10 September 2021
|
10 September 2026
|
| View |
|
DR-XY47377
|
Ertapenem
|
Ertasure
|
1 g
|
Lyophilized Powder For Injection (IV/IM)
|
Antibacterial (Carbapenem)
|
Gland Pharma Limited
Plot No.:
|
India
|
-
|
24 September 2021
|
24 September 2026
|
| View |
|
DR-XY47378
|
Ascorbic Acid
|
None
|
600 mg (equivalent to 674.92 mg Sodium Ascorbate)
|
Capsule
|
-
|
Northfield Laboratories Inc.
|
Philippines
|
-
|
10 September 2021
|
10 September 2026
|
| View |
|
DR-XY47379
|
Ciprofloxacin (as Hydrochloride)
|
Ciplume
|
3 mg/mL (0.3% w/v)
|
Sterile Ophthalmic Solution
(Drops)
|
Antibacterial (Fluoroquinolone)
|
Axa Parenterals Limited
|
India
|
-
|
15 September 2021
|
15 September 2026
|
| View |
|
DR-XY47380
|
Anastrozole
|
Anzonat
|
1mg
|
Film-Coated Tablet
|
-
|
Natco Pharma Limited
|
India
|
Initial (Reconstruction)
|
08 November 2022
|
15 September 2026
|
| View |
|
DR-XY47382
|
Ambroxol Hydrochloride
|
Lobrix
|
15 mg/5 mL
|
Syrup (Grape Flavor)
|
-
|
Y.S.P. Industries (M) Sdn. Bhd
|
malaysia
|
-
|
11 November 2021
|
14 September 2026
|
| View |
|
DR-XY47383
|
Ascorbic Acid + Zinc
|
Zeta-C
|
500 mg (equivalent to 568.18 mg Sodium Ascorbate)/10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
-
|
Northfield Laboratories Inc.
|
Philippines
|
-
|
22 September 2021
|
22 September 2026
|
| View |
|
DR-XY47384
|
Ascorbic Acid + Zinc
|
Pure-Cee'Z Capsule
|
500 mg/15 mg (equivalent to 41.182 mg Zinc Sulfate Monohydrate) per Capsule
|
Capsule
|
Vitamin/Mineral
|
Growrich Manufacturing Inc.
|
Philippines
|
-
|
14 September 2021
|
14 September 2026
|
| View |
|
DR-XY47385
|
Cilostazol
|
Cilosol 50
|
50 mg
|
Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
-
|
15 September 2021
|
15 September 2026
|
| View |
|
DR-XY47386
|
Ascorbic Acid + Zinc
|
Sodazen
|
533.40 mg (equivalent to 600 mg Sodium Ascorbate) /
10 mg (equivalent to 27.45 mg Zinc Sulfate Monohydrate)
|
Capsule
|
-
|
Interchemex Laboratories, Inc.
|
Philippines
|
-
|
12 October 2021
|
12 October 2024
|