| View |
|
DR-XY45971
|
Nepafenac
|
Nepalact
|
1 mg/mL (0.1% w/v)
|
Sterile Ophthalmic Suspension (Eye Drops)
|
Non-Steroidal Anti-inflammatory Drug (NSAID)
|
Sun Pharmaceutical Medicare Limited
|
India
|
Initial (from Monitored Release)
|
07 August 2024
|
07 August 2029
|
| View |
|
DR-XY45974
|
d-Alpha Tocopherol + d-Alpha Tocopheryl Acetate (Vit.E)
|
None
|
100 IU
|
Softgel Capsule
|
Vitamin
|
Nutra Manufacturing Inc.
|
U.S.A.
|
Renewal
|
09 June 2022
|
03 August 2027
|
| View |
|
DR-XY45980
|
Sevelamer Carbonate
|
Renvela
|
800 mg
|
Powder for Oral Suspension
|
-
|
Rovi Pharma Industrial Services, S.A.
|
Spain
|
Initial (from Monitored Release)
|
18 October 2023
|
14 August 2027
|
| View |
DR-XY45981_PI_01.pdf
|
DR-XY45981
|
Ticagrelor
|
Brilinta
|
60 mg
|
Film-Coated Tablet
|
Anthrombotic Agent (Platelet aggregation inhibitors
excl. heparin)
|
Astrazeneca AB
|
Sweden
|
Initial (Correction)
|
10 May 2024
|
15 August 2027
|
| View |
|
DR-XY45983
|
Sugammadex (As Sodium)
|
Bridion
|
100mg/mL
|
Solution For Injection (IV)
|
Antidote
|
Patheon Manufacturing Services, LLC
|
United States of America
|
Initial (from Monitored Release)
|
25 October 2022
|
11 August 2027
|
| View |
|
DR-XY45985
|
CALCITRIOL
|
Ostovel
|
0.25mcg
|
Softgel Capsule
|
Vitamin
|
Pt. Novell Pharmaceutical Laboratories
|
Indonesia
|
Renewal
|
25 April 2022
|
24 August 2027
|
| View |
|
DR-XY45986
|
Fenofibrate + Simvastatin
|
Cholib
|
145 mg/20 mg
|
Film-Coated Tablet
|
-
|
Fournier Laboratories Ireland Limited
|
Ireland
|
Monitored Release (MR) to Initial
|
28 April 2023
|
14 August 2027
|
| View |
|
DR-XY45987
|
Fenofibrate + Simvastatin
|
Cholib
|
145 mg/40 mg
|
Film-Coated Tablet
|
-
|
Fournier Laboratories Ireland Limited
|
Ireland
|
Monitored Release (MR) to Initial
|
28 April 2023
|
14 August 2027
|
| View |
|
DR-XY45993
|
Tamsulosin hydrochloride
|
Prostanil MR
|
400mcg
|
Prolonged-Release Capsule
|
Alpha-Adrenoreceptor Antagonist
|
Aristopharma Ltd.
|
Bangladesh
|
Automatic Renewal
|
12 July 2022
|
23 August 2027
|
| View |
|
DR-XY45996
|
Multivitamins + L-Lysine Hydrochloride + Buclizine Hydrochloride
|
Appetamine
|
Formulation: Each 5 ml (1 teaspoonful) syrup contains: Thiamine Hydrochloride (Vitamin B1)-10mg
Cyanocobalamin (Vitamin B12)-5 mcg Riboflavin -5-Phosphate sodium (Vitamin B2)-1.4 mg
Ascorbic Acid (Vitamin C)-100 mg Nicotinamide (Vitamin B3)-20 mg L-Lysine HCI-300 mg Pyridoxine Hydrochloride (Vitamin B6)-5 mg
Buclizine HCI-5 mg
|
Syrup
|
Vitamins / Appetite Stimulant
|
La Croesus Pharma, Inc.
|
Philippines
|
Renewal
|
29 June 2024
|
05 September 2029
|
| View |
|
DR-XY45997
|
Multivitamins + L-Lysine Hydrochloride + Buclizine Hydrochloride
|
Appetamine
|
THIAMINE MONONITRATE- 10 MG/RIBOFLAVIN-1.8MG/NICOTINAMIDE-20MG/PYRIDOXINE HCL-5MG/CYANOCOBALAMIN-6MCG/ASCORBIC ACID-150MCG/L-LYSINE HCL-300MG/BUCLIZINE HCL-25MG
|
Capsule
|
Vitamins / Appetite Stimulant
|
La Croesus Pharma, Inc.
|
Philippines
|
Renewal
|
02 August 2024
|
05 September 2029
|
| View |
|
DR-XY46001
|
Ascorbic acid (as Sodium Ascorbate)
|
None
|
500mg
|
Capsule
|
Vitamin
|
Hizon Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
05 September 2022
|
25 August 2027
|
| View |
|
DR-XY46004
|
Isoxsuprine Hydrochloride
|
Isoxulide
|
5mg/ mL
|
Solution for Injection (IM/IV)
|
PERIPHERAL VASODILATORS (2-AMINO-1-PHENYLETHANOL DERIVATIVES)
|
Gufic Biosciences Ltd.
|
India
|
Renewal
|
15 June 2022
|
30 August 2027
|
| View |
|
DR-XY46009
|
Metoclopramide hydrochloride
|
Meclop
|
5mg/mL
|
Solution for Injection
|
-
|
Jiangxi Xierkangtai Pharmaceutical Co., Ltd.
|
China
|
Automatic Renewal
|
07 January 2023
|
11 September 2027
|
| View |
|
DR-XY46011
|
Tafluprost + Timolol (As Maleate)
|
Tapcom
|
15 mcg/ 5 mg per mL
|
Ophthalmic Solution
|
Antiglaucoma
|
Santen Pharmaceutical Co., Ltd. (Shiga Plant)
|
Japan
|
initial (from Monitored Release)
|
25 October 2022
|
11 September 2027
|
| View |
|
DR-XY46012
|
Tafluprost + Timolol Maleate
|
Tapcom-S
|
15mcg/ 5mg/ mL
|
Ophthalmic Solution
|
Anti-glaucoma
|
Laboratoire Unither
|
France
|
Compliance MR
|
11 September 2017
|
11 September 2025
|
| View |
|
DR-XY46013
|
Potassium Chloride
|
Ktabsr
|
750 mg
|
Extended-Release Tablet
|
Mineral Supplement (Potassium)
|
Centaur Pharmaceutical Pvt. Ltd.
|
India
|
Initial (Variation)
|
08 February 2024
|
08 February 2029
|
| View |
|
DR-XY46016
|
Pitavastatin Calcium
|
Pitator
|
2 mg
|
Film-Coated Tablet
|
-
|
Orient Pharma Co., Ltd.
|
Taiwan
|
Initial (from Monitored Release status
|
04 December 2023
|
08 September 2027
|
| View |
|
DR-XY46017
|
Pemetrexed (as disodium)
|
Pemcord 100
|
100mg
|
Lyophilized Powder For Concentrate for Solution for Infusion (IV)
|
-
|
Intas Pharmaceuticals Limited
|
India
|
Renewal
|
30 May 2023
|
07 November 2027
|
| View |
|
DR-XY46018
|
Pemetrexed (as disodium)
|
Pemcord 500
|
500 mg
|
Lyophilized Powder For Concentrate fo Solution for Infusion (IV)
|
-
|
Intas Pharmaceuticals Limited
|
India
|
Renewal
|
30 May 2023
|
07 September 2027
|