| View |
|
DR-XY48488
|
Entecavir (as Monohydrate)
|
Envira 0.5
|
500 mcg
|
Film Coated Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
23 November 2022
|
23 November 2027
|
| View |
|
DR-XY48489 (For Export Only)
|
Dextromethorphan Hydrobromide
|
Robitussin DX
|
30mg/10mL
|
Syrup
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial [OTC]
|
23 November 2022
|
23 November 2027
|
| View |
|
DR-XY48490
|
Zinc Chelate
|
None
|
30 mg
|
Tablet
|
-
|
Nexgen Pharma, Inc.
|
United States of America
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
|
DR-XY48491
|
Acetylcysteine + Zinc
|
Exflem Plus
|
600 mg / 5 mg
|
Film-Coated Tablet
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
Monitored Release (MR)
|
25 November 2022
|
25 November 2027
|
| View |
DR-XY48492_PI_01.pdf
|
DR-XY48492
|
Lenalidomide
|
Lenzest 25
|
25 mg
|
Capsule
|
Immunosuppressant
|
Sun Pharmaceutical Industries Limited
|
India
|
Monitored Release (Reconstruction)
|
24 May 2024
|
25 November 2027
|
| View |
DR-XY48493_PI_01.pdf
|
DR-XY48493
|
Lenalidomide
|
Lenzest 10
|
10 mg
|
Capsule
|
Immunosuppressant
|
Sun Pharmaceuticals Industries Ltd.
|
India
|
Monitored Release (Reconstruction)
|
27 June 2024
|
25 November 2027
|
| View |
DR-XY48494_PI_01.pdf
|
DR-XY48494
|
Ondansetron (as hydrochloride dihydrate)
|
Frenvo
|
4 mg/5 mL
|
Syrup
|
-
|
Delpharm Bladel B.V.
|
Netherlands
|
Monitored Release
|
25 November 2022
|
25 November 2027
|
| View |
|
DR-XY48495
|
Deferasirox
|
Defetor 500
|
500 mg
|
Dispersible Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
25 November 2022
|
25 November 2027
|
| View |
|
DR-XY48496
|
Deferasirox
|
Defetor 250
|
250 mg
|
Dispersible Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
25 November 2022
|
25 November 2027
|
| View |
|
DR-XY48497
|
Deferasirox
|
Defetor 125
|
125mg
|
Dispersible Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
25 November 2022
|
25 November 2027
|
| View |
|
DR-XY48498
|
Cetrorelix (as Acetate)
|
Asporelix
|
250mcg
|
Lyophilized Powder For Injection (SC)
|
-
|
Bharat Serums and Vaccines Limited
|
India
|
Initial
|
16 December 2022
|
16 December 2027
|
| View |
|
DR-XY48499 (FOR EXPORT ONLY)
|
Brompheniramine Maleate + Phenylephrine
|
Dimetapp
|
2mg/5mg per 5 mL
|
Elixir
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
25 November 2022
|
25 November 2027
|
| View |
|
DR-XY48500 (FOR EXPORT ONLY)
|
Brompheniramine Maleate + Phenylephrine Hydrochloride
|
Dimetapp Colour Free Elixir
|
2mg/5mg per 5mL
|
Elixir
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
25 November 2022
|
25 November 2027
|
| View |
|
DR-XY48501 (FOR EXPORT ONLY)
|
Brompheniramine Maleate + Phenylephrine
Hydrochloride + Dextromethorphan Hydrobromide
|
Dimetapp DM Cold and Cough Elixir (Colour Free)
|
2mg/5mg/10mg per 5mL
|
Elixir
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
25 November 2022
|
25 November 2027
|
| View |
|
DR-XY48502 (FOR EXPORT ONLY)
|
Brompheniramine Maleate + Phenylephrine
Hydrochloride + Dextromethorphan Hydrobromide
|
Dimetapp DM Cold and Cough Elixir
|
2 mg/5 mg/10 mg per 5 mL
|
Elixir
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
25 November 2022
|
25 November 2027
|
| View |
DR-XY48503_PI_01.pdf
|
DR-XY48503
|
Tafenoquine (as Succinate)
|
Kozenis
|
150mg
|
Film-coated tablet
|
-
|
Piramal Enterprises Limited
|
India
|
Monitored Release
|
25 November 2022
|
25 November 2025
|
| View |
|
DR-XY48504
|
Tretinoin + Hydroquinone
|
Maxi-Peel Solution No. 4
|
25 mg (0.025% w/w)/4 g (4% w/w) per 100 g
|
Topical Solution
|
-
|
Splash Corporation
|
Philippines
|
Initial (OTC)
|
25 November 2022
|
25 November 2027
|
| View |
|
DR-XY48505
|
Ascorbic Acid + Zinc+ Cholecalciferol (Vitamin D3)
|
Corcee Plus
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate)/10 mg (equivalent to 70 mg Zinc Gluconate)/1,000 IU
|
Capsule
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
28 November 2022
|
28 November 2027
|
| View |
|
DR-XY48506
|
Digoxin
|
Lanoxin
|
250 mcg/mL (500 mcg/2mL)
|
Solution For Injection
|
-
|
Cenexi
|
France
|
Initial (correction)
|
10 February 2023
|
28 November 2027
|
| View |
|
DR-XY48507
|
Atracurium Besilate
|
Kabitran
|
10mg/mL
|
Solution for Injection (IV)
|
-
|
PT. Ethica Industri Farmasi (PT. Ethica)
|
Indonesia
|
Initial
|
28 November 2022
|
28 November 2027
|