| View |
|
DR-XY46847
|
Diclofenac Diethylamine
|
Diclosafe Forte
|
23.2mg/g (2.32% w/w)
|
Topical Emulsion Gel
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
-
|
16 March 2020
|
16 March 2025
|
| View |
|
DR-XY46848
|
Dexketoprofen (as trometamol)
|
Ketofenax
|
50mg/2mL
|
Solution for Injection or Concentrate for Solution for Infusion (I.V./I.M.)
|
-
|
S.c Rompharm Company S.R.L.
|
Romania
|
Monitored Release (Reconstruction)
|
11 March 2022
|
18 March 2025
|
| View |
|
DR-XY46849
|
Dexketoprofen (as trometamol)
|
Dalyx
|
50mg/2mL
|
Solution for Injection or Concentrate for Solution for Infusion (I.V./I.M.)
|
-
|
S.c Rompharm Company S.R.L.
|
Romania
|
-
|
11 March 2022
|
11 March 2025
|
| View |
|
DR-XY46850
|
Nicardipine Hydrochloride
|
Zicard
|
1 mg/mL (10 mg/10 mL)
|
Solution for Injection for IV Infusion
|
-
|
AJU PHARM CO., LTD.
|
Korea
|
Renewal
|
21 December 2023
|
13 March 2027
|
| View |
|
DR-XY46851
|
Amorolfine (as hydrochloride)
|
Kolmarol
|
2.5mg per g (0.25%w/w)
|
Cream
|
-
|
KOLMAR KOREA CO., LTD.
|
Korea
|
-
|
13 March 2020
|
13 March 2025
|
| View |
DR-XY46852_PI_01.pdf
|
DR-XY46852
|
Lopinavir + Ritonavir
|
RITOCOM
|
100mg/25mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited
|
India
|
-
|
18 March 2020
|
18 March 2025
|
| View |
|
DR-XY46853
|
Guiafenesin
|
Woods Peppermint Expectorant
|
200 mg/ 7 mL
|
Syrup
|
-
|
PT. Bintang Toedjoe (Tujuh)
|
Indonesia
|
-
|
27 May 2020
|
27 May 2025
|
| View |
DR-XY46855_PI_01.pdf
|
DR-XY46855
|
Sofosbuvir
|
Capribuvir
|
400mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited, Unit V
|
India
|
-
|
20 January 2021
|
24 March 2025
|
| View |
DR-XY46856_PI_01.pdf
|
DR-XY46856
|
Abacavir (as Sulfate) + Lamivudine
|
Abalam
|
600mg/300mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited Unit V
|
India
|
-
|
24 March 2020
|
24 March 2025
|
| View |
|
DR-XY46857
|
Butamirate Citrate
|
None
|
50 mg
|
Sustained-Release Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
17 December 2020
|
17 December 2025
|
| View |
|
DR-XY46858
|
Diclofenac Diethylamine
|
Diclosafe
|
11-6mg/g (1.16%w/w)
|
Topical Emulsion Gel
|
-
|
KUSUM HEALTHCARE PVT. LTD
|
India
|
Initial
|
25 March 2020
|
25 March 2025
|
| View |
|
DR-XY46859
|
Cetirizine Dihydrochloride
|
Allerteen
|
10 mg
|
Film-Coated Tablet
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
-
|
25 March 2020
|
25 March 2025
|
| View |
|
DR-XY46860
|
Multivitamins
|
Renal Vite Plus
|
(see reverse for formulation)
|
Capsule
|
-
|
DIAMOND LABORATORIES INC.
|
Philippines
|
Initial
|
26 March 2020
|
26 March 2025
|
| View |
DR-XY46861_PI_01.pdf
|
DR-XY46861
|
Ceftazidime (as pentahydrate) + Avibactam (as Sodium)
|
Zavicefta
|
2g/500mg
|
Powder For Concentrate For IV Infusion
|
-
|
GlaxoSmithKline Manufacturing S.P.A.
|
Italy
|
-
|
26 March 2020
|
26 March 2025
|
| View |
|
DR-XY46862
|
Dextromethorphan Hydrobromide + Phenylpropanolamine Hydrochloride + Chlorpheniramine Maleate + Sodium Citrate
|
AC-NEX PH
|
15mg/ 10mg/ 2mg/ 200mg per 5mL
|
Syrup
|
Antitussive/Decongestant/Antihistamine
|
La Croesus Pharma Inc.
|
Philippines
|
-
|
30 March 2020
|
30 March 2025
|
| View |
|
DR-XY46863
|
Moxifloxacin (As Hydrochloride)
|
None
|
400mg
|
Film-Coated Tablet
|
-
|
Mylan Laboratories Limited
|
India
|
Initial
|
31 March 2020
|
31 March 2025
|
| View |
DR-XY46864_PI_01.pdf
|
DR-XY46864
|
Ponatinib (as Hydrocloride)
|
Iclusig
|
15mg
|
Film Coated Tablet
|
-
|
Patheon Inc.
|
Canada
|
-
|
21 April 2020
|
21 April 2025
|
| View |
DR-XY46865_PI_01.pdf
|
DR-XY46865
|
Citicoline
|
Citrinex
|
500 mg
|
Film-Coated Tablet
|
-
|
CB Healthcare
|
India
|
Initial
|
31 March 2023
|
31 March 2028
|
| View |
|
DR-XY46866
|
Ascorbic Acid + Zinc
|
None
|
500 mg/10 mg
|
CAPSULE
|
-
|
Northfield Laboratories., Inc.
|
Philippines
|
Initial
|
02 April 2020
|
02 April 2025
|
| View |
|
DR-XY46867
|
Ascorbic Acid + Zinc
|
None
|
500 mg/10 mg
|
Capsule
|
-
|
Northfield Laboratories., Inc.
|
Philippines
|
Initial
|
26 November 2020
|
02 April 2025
|